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Subsidiary Legislation (Transposition of Directive 2013/55/EU)

62 Articles / Provisions · Malta
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Table of Provisions (62)

Preamble Reg. 1 Reg. 2 Reg. 3 Reg. 4 Amends regulation 6 of the principal regulations. Reg. 5 Adds new regulation to the principal regulations. Reg. 6A Reg. 7 Reg. 8 Reg. 9 Amendments to the Mutual Recognition of Qualifications of Veterinary Surgeons Regulations. Reg. 10 Amends regulation 2 of the principal regulations. Reg. 11 Reg. 12 Amendments to the Recognition of Professional Qualifications Regulations. Reg. 13 Amends regulation 2 of the principal regulations. Reg. 14 Amends regulation 3 of the principal regulations. Reg. 15 Reg. 16 Reg. 17 Amends regulation 5 of the principal regulations. Reg. 18 Adds new regulation to the principal regulations. Reg. 19 Adds new regulation to the principal regulations. Reg. 20 Reg. 21 Reg. 22 Reg. 23 Reg. 24 Adds new regulation to the principal regulations. Reg. 25 Reg. 26 Adds new regulation to the principal regulations. Reg. 27 Reg. 28 Reg. 29 Amends regulation 10 of the principal regulations. Reg. 30 Amends regulation 12 of the principal regulations. Reg. 31 Amends regulation 13 of the principal regulations. Reg. 32 Reg. 33 Reg. 34 Amends regulation 16 of the principal regulations. Reg. 35 Deletes regulation 17 of the principal regulations. Reg. 36 Amends regulation 18 of the principal regulations. Reg. 37 Amends regulation 19 of the principal regulations. Reg. 38 Reg. 39 Reg. 40 Reg. 41 Reg. 42 Reg. 43 Adds new regulation to the principal regulations. Reg. 44 Adds new regulation to the principal regulations. Reg. 45 Reg. 46 Deletes Schedules II and III to the principal regulations. Reg. 47 Amends Schedule III to the principal regulations. Reg. 48 Amendments to the Minimum Training Conditions (Health Care Professions) Regulations. Reg. 49 Amends regulation 2 of the principal regulations. Reg. 50 Reg. 51 Amends regulation 4 of the principal regulations. Reg. 52 Amends regulation 5 of the principal regulations. Reg. 53 Amends regulation 6 of the principal regulations. Reg. 54 Amends regulation 7 of the principal regulations. Reg. 55 Adds new regulation to the principal regulations. Reg. 56 Reg. 57 Reg. 58 Reg. 59 Reg. 60 Reg. 61

Statutory Text (62 Articles)

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

L.N. 270 of 2016

VARIOUS LAWS (TRANSPOSITION OF DIRECTIVE

2013/55/EU) (AMENDMENT) ACT, 2016

(ACT NO. XXXIV of 2016)

Subsidiary Legislation (Transposition of Directive 2013/55/EU)

(Amendment) Regulations, 2016

IN exercise of the powers conferred by article 38 of the Various

Laws (Transposition of Directive 2013/55/EU) (Amendment) Act,

2016, the Minister for Education and Employment has made the

following regulations:-

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

The title of these regulations is the Subsidiary Legislation Citation.

(Transposition of Directive 2013/55/EU) (Amendment) Regulations,

2016. Part I

Amendments to the Accountancy Profession (Provision of

Accountancy Services on a Temporary and Occasional Basis)

Regulations

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

(1) This Part amends the Accountancy Profession Amendments to

(Provision of Accountancy Services on a Temporary and Occasional the

Accountancy

Basis) Regulations, and it shall be read and construed as one with the Profession

(Provision of

Accountancy Profession (Provision of Accountancy Services on a Accountancy

Temporary and Occasional Basis) Regulations hereinafter in this Part Services

Temporary and

referred to as "the principal regulations".

Occasional

Basis)

Regulations.

(2) The regulations included in this Part implement certain

provisions of Commission Directive 2013/55/EU, and they are made

by virtue of the powers conferred by article 38 of the Various Laws

(Transposition of Directive 2013/55/EU) (Amendment) Act, 2016, on

the Minister for Education and Employment, in consultation with the

Minister for Finance, and on the recommendation of the Accountancy

Board, in pursuance of the powers conferred by articles 8 and 8A of

the Accountancy Profession Act.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 4 of the principal regulations shall be amended Amends

regulation 4 of

as follows

the principal

regulations.

(a)

the current regulation shall be re-numbered as sub-

regulation (1) thereof;

(b) in the proviso to paragraph (a) of sub-regulation (1),

as re-numbered thereof, for the words "two years" there shall be

substituted the words "one year"; and

(c)

immediately after sub-regulation (1), as re-

numbered, thereof, there shall be added the following new sub-

regulation

"(2) The Board shall ensure that any controls on

the language competency of a temporary service provider

are limited to the knowledge of one official language of

Malta, and only carried out after recognition of the

professional qualifications of the temporary service

provider. Controls may be imposed by the Board in cases

where there is a serious and concrete doubt about the

sufficiency of the temporary service provider’s language

knowledge in respect of the accountancy services the

temporary service provider intends to pursue. Any

language controls shall be proportionate to the activity to

be pursued, and shall be subject to appeal in accordance

with article 15B of the Act.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

In paragraph (c) of sub-regulation (2) of regulation 6 of the

principal regulations, for the words "two years" there shall be

substituted the words "one year".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 6 of the principal regulations,

there shall be added the following regulation

" Access to

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Submission

of

the

required

provide

declaration by a temporary service provider in

accountancy

accordance with regulation 6 shall entitle that

services.

temporary service provider to have access to

provide accountancy services in the entire

territory of Malta.".

Part II

Amendments to the Tourist Guides Regulations

6. (1) This Part amends the Tourist Guides Regulations

and it shall be read and construed as one with the Tourist Guides

Regulations, hereinafter in this Part referred to as "the principal

regulations".

(2) The regulations included in this Part implement certain

provisions of Commission Directive 2013/55/EU, and they are made

by virtue of the powers conferred by article 38 of the Various Laws

(Transposition of Directive 2013/55/EU) (Amendment) Act, 2016, on

the Minister for Education and Employment, in consultation with the

Minister for Tourism, on the recommendation of the Malta Tourism

Authority, in pursuance of the powers conferred by article 47 of the

Malta Travel and Tourism Act.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

In the proviso to sub-regulation (3) of regulation 3 of the Amends

principal regulations, for the words "two years" there shall be regulation

the principal

substituted the words "one year".

regulations.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 7 of the principal regulations shall be amended Amends

regulation 7 of

as follows

the principal

regulations.

(a)

in the proviso to paragraph (a) of sub-regulation (1)

thereof, for the words "twenty-four months" there shall be

substituted the words "one year";

(b) in paragraph (c) of sub-regulation (4) thereof, for the

words "twenty-four months" there shall be substituted the words

"one year"; and

(c)

immediately after sub-regulation (8) thereof, there

shall be added the following new sub-regulations

"(9) Submission

of

the

required

declaration by a temporary service provider in

accordance with sub-regulation (3) shall entitle

that temporary service provider to have access

to provide tourist guiding services in the entire

territory of Malta.

(10) The Authority shall ensure that any

controls on the language competency of a

temporary service provider are limited to the

knowledge of one official language of Malta,

and only carried out after recognition of the

professional qualifications of the temporary

service provider. Controls may be imposed by

the Authority in cases where there is a serious

and concrete doubt about the sufficiency of the

temporary service provider’s language

knowledge in respect of the tourist guiding

services the temporary service provider intends

to pursue. Any language controls shall be

proportionate to the activity to be pursued, and

shall be subject to appeal in accordance with

the provisions of the Third Schedule to the Act,

on payment of the fee set out in the Fees

(Tourism) Regulations.".

Part III

Amendments to the Mutual Recognition of Qualifications

of Veterinary Surgeons Regulations

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

(1) This Part amends the Mutual Recognition of

Qualifications of Veterinary Surgeons Regulations and it shall be read

and construed as one with the Mutual Recognition of Qualifications

of Veterinary Surgeons Regulations, hereinafter in this Part referred

to as "the principal regulations".

(2) The regulations included in this Part implement certain

provisions of Commission Directive 2013/55/EU, and they are made

by virtue of the powers conferred by article 38 of the Various Laws

(Transposition of Directive 2013/55/EU) (Amendment) Act, 2016, on

the Minister for Education and Employment, in consultation with the

Minister for Sustainable Development, the Environment and Climate

Change, in pursuance of the powers conferred by article 45A of the

Veterinary Services Act.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 2 of the principal regulations shall be amended

as follows

(a)

paragraphs (vii) to (xii) thereof shall be re-numbered

as paragraphs (viii) to (xiii) respectively; and

(b) immediately following paragraph (vi) thereof there

shall be added the following new definition

"(vii) "European Credit Transfer and Accumulation

System" or "ECTS credits" means the credit system for

higher education used in the European Higher Education

Area;".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 4 of the principal regulations shall be amended Amends

regulation 4 of

the principal

regulations.

(a)

for sub-regulation (1) thereof there shall be

substituted the following

"(1) The Council shall require persons wishing to

take up and pursue the profession of veterinary surgeon to

hold a diploma, certificate or other evidence of formal

qualifications in veterinary medicine as listed in the

Schedule I, which guarantees that during his complete

training period the applicant has acquired

(a) adequate knowledge of the sciences on

which the activities of a veterinary surgeon are

based and of European Union law relating to those

activities;

(b) adequate knowledge of the structure,

functions, behaviour and physiological needs of

animals, as well as the skills and competences

needed for their husbandry, feeding, welfare,

reproduction and hygiene in general;

(c) the clinical, epidemiological and

analytical skills and competences required for the

prevention, diagnosis and treatment of the diseases

of animals, including anaesthesia, aseptic surgery

and

painless

death,

whether

considered

individually or in groups, including specific

knowledge of the diseases which may be

transmitted to humans;

(d) adequate

knowledge,

skills

and

competences for preventive medicine, including

competences relating to inquiries and certification;

(e) adequate knowledge of the hygiene and

technology

involved

in

the

production,

manufacture and putting into circulation of animal

feedstuffs or foodstuffs of animal origin intended

for human consumption, including the skills and

competences required to understand and explain

good practice in this regard;

(f) the knowledge, skills and competences

required for the responsible and sensible use of

veterinary medicinal products, in order to treat the

animals and to ensure the safety of the food chain

and the protection of the environment."; and

(b) in sub-regulation (2) thereof, for words "full-time

instruction" there shall be substituted the words "full-time

instruction, which may in addition be expressed with the

equivalent ECTS credits,".

Part IV

Amendments to the Recognition of Professional Qualifications

Regulations

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

(1) This Part amends the Recognition of Professional

Qualifications Regulations and it shall be read and construed as one

with the Recognition of Professional Qualifications Regulations,

hereinafter in this Part referred to as "the principal regulations".

(2) The regulations included in this Part implement certain

provisions of Commission Directive 2013/55/EU, and they are made

by virtue of the powers conferred on the Minister for Education and

Employment by article 38 of the Various Laws (Transposition of

Directive 2013/55/EU) (Amendment) Act, 2016, and article 8 of the

Mutual Recognition of Qualifications Act.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 2 of the principal regulations shall be amended

as follows

(a)

the figure "(1)" shall be deleted;

(b) for the definition "aptitude test" there shall be

substituted the following

" "aptitude test" means a test of the professional

knowledge, skills and competences of the applicant,

carried out or recognised by the designated authority with

the aim of assessing the ability of the applicant to pursue a

regulated profession in Malta. In order to permit this test to

be carried out, designated authorities shall draw up a list of

subjects which, on the basis of a comparison of the

education and training required in Malta and that received

by the applicant, are not covered by the diploma or other

evidence of formal qualifications possessed by the

applicant. The aptitude test must take account of the fact

that the applicant is a qualified professional in the home

Member State or the Member State from which the

applicant comes. It shall cover subjects to be selected from

those on the list, knowledge of which is essential in order

to be able to pursue the profession in question in Malta.

The test may also cover knowledge of the professional

rules applicable to the activities in question in Malta. The

detailed application of the aptitude test and the status, in

Malta, of the applicant who wishes to prepare himself for

the aptitude test in Malta shall be determined by the

designated authorities concerned;"

(c)

the definition "common platforms" shall be deleted;

(d) immediately after the definition "aptitude test" there

shall be added the following new definition

" "European Professional Card" means an

electronic certificate proving either that the professional

has met all the necessary conditions to provide services in

a host Member State on a temporary and occasional basis

or the recognition of professional qualifications for

establishment in a host Member State;";

(e)

immediately after the definition "European

Professional Card" there shall be added the following new

definition

" "European Credit Transfer and Accumulation

System" or "ECTS credits" means the credit system for

higher education used in the European Higher Education

Area;";

(f)

immediately after the definition "evidence of formal

qualifications" there shall be added the following new

definition

" "IMI" means the Internal Market Information

System;";

(g) immediately after the definition "IMI" there shall be

added the following new definition

" "lifelong learning" means all general education,

vocational education and training, non-formal education

and informal learning undertaken throughout life, resulting

in an improvement in knowledge, skills and competences,

which may include professional ethics;"

(h) immediately after the definition "migrant" there

shall be added the following new definition

" "overriding reasons of general interest" means

reasons recognised as such in the case-law of the Court of

Justice of the European Union;";

(i)

for the definition "professional experience" there

shall be substituted the following

" "professional experience" means the actual and

lawful full-time or equivalent part-time pursuit of the

profession concerned in a Member State;";

(j)

immediately after the definition "professional

qualifications" there shall be added the following new

definition

"professional traineeship" means a period of

professional practice carried out under supervision

provided it constitutes a condition for access to a regulated

profession, and which can take place either during or after

completion of an education leading to a diploma;"; and

(k) for the definition "substantially different matters"

there shall be substituted the following

" "substantially different matters" means matters in

respect of which knowledge, skills and competences

acquired are essential for pursuing the profession and with

regard to which the training received by the migrant shows

significant differences in terms of content from the training

required by the host Member State.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 3 of the principal regulations shall be amended

as follows

(a)

the present regulation shall be renumbered as sub-

regulation (1) thereof; and

(b) immediately after sub-regulation (1), as re-

numbered, thereof, there shall be added the following new sub-

regulations

"(2) These regulations shall also apply to all

nationals of a Member State who have pursued a

professional traineeship outside the home Member State.

(3) These regulations shall not apply to notaries

who are appointed by official act of government.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 4 of the principal regulations shall be amended Amends

regulation 4 of

as follows

the principal

regulations.

(a)

for sub-regulation (3) thereof there shall be

substituted the following

"(3) The recognition of professional qualifications

shall allow migrants to gain access in Malta to the same

profession as that for which they are qualified in their

home Member State and to pursue it in Malta under the

same conditions as Maltese nationals

Provided that partial access to a profession in

Malta shall be granted under the conditions laid down in

regulation 6F.”; and

(b)

sub-regulation (5) thereof shall be deleted.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 4 of the principal regulations Adds new

regulation to the

there shall be added the following new regulation

principal

regulations.

" Knowledge of

4A. (1) Professionals benefiting from

languages.

the recognition of professional qualifications

shall have a knowledge of languages necessary

for practising the profession in Malta.

(2) Designated authorities shall ensure

that any controls carried out to ensure

compliance with the obligation under sub-

regulation (1) shall be limited to the knowledge

of one official language of Malta.

(3) Controls carried out in accordance

with sub-regulation (2) may be imposed if the

profession to be practised has patient safety

implications. Controls may be imposed in

respect of other professions in cases where

there is a serious and concrete doubt about the

sufficiency of the professional’s language

knowledge in respect of the professional

activities which that professional intends to

pursue.

(4) Controls may be carried out only

after the issuance of a European Professional

Card in accordance with regulation 6D or after

the recognition of a professional qualification,

as the case may be.

(5) Any language controls shall be

proportionate to the activity to be pursued, and

shall be subject to appeal in accordance with

article 7 of the Act.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 5 of the principal regulations shall be amended

as follows

(a)

paragraph (a) of sub-regulation (3) thereof shall be

substituted by the following

"(a) The designated authorities shall exchange

information with competent authorities of other Member

States regarding disciplinary action or criminal sanctions

taken or any other serious, specific circumstances which

are likely to have consequences for the pursuit of activities

under these regulations. In so doing, they shall respect

personal data protection rules provided by law."; and

(b) immediately after sub-regulation (3) thereof there

shall be added the following new sub-regulation

"(4) For the purposes of sub-regulations (2) and

(3), the designated authorities shall use IMI.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 5 of the principal regulations,

there shall be added the following new regulation

" Information to

5A. (1) The National Commission for

be given to

Further and Higher Education shall inform the

competent

competent authorities of all other Member

authorities of all

other Member

States about a professional whose pursuit in the

States.

territory of Malta of the following professional

activities in their entirety or parts thereof has

been restricted or prohibited, even temporarily,

by national authorities or courts

(a)

doctor of medicine and of

general practice possessing evidence of a

formal qualification referred to in points

5.1.1 and 5.1.4 of Annex V of Directive

2005/36/EC;

(b) specialist doctor of medicine

possessing a title referred to in point

5.1.3 of Annex V of Directive 2005/36/

EC;

(c)

nurse responsible for general

care possessing evidence of a formal

qualification referred to in point 5.2.2 of

Annex V of Directive 2005/36/EC;

(d) dental practitioner possessing

evidence of a formal qualification

referred to in point 5.3.2 of Annex V of

Directive 2005/36/EC;

(e) specialist dentists possessing

evidence of a formal qualification

referred to in point 5.3.3 of Annex V of

Directive 2005/36/EC;

(f)

veterinary surgeon possessing

evidence of a formal qualification

referred to in point 5.4.2 of Annex V of

Directive 2005/36/EC;

(g) midwife possessing evidence

of a formal qualification referred to in

point 5.5.2 of Annex V of Directive

2005/36/EC;

(h) pharmacist

possessing

evidence of a formal qualification listed

in point 5.6.2 of Annex V of Directive

2005/36/EC;

(i)

holders

of

certificates

mentioned in point 2 of Annex VII of

Directive 2005/36/EC attesting that the

holder completed a training which

satisfies the minimum requirements listed

in Articles 24, 25, 31, 34, 35, 38, 40, or

44 respectively of Directive 2005/36/EC,

but which started earlier than the

reference dates of the qualifications listed

in points 5.1.3, 5.1.4, 5.2.2, 5.3.2, 5.3.3,

5.4.2, 5.5.2, 5.6.2 of Annex V of

Directive 2005/36/EC;

(j)

holders of certificates of

acquired rights as referred to in Articles

23, 27, 29, 33, 33a, 37, 43 and 43a of

Directive 2005/36/EC;

(k) other professionals exercising

activities that have patient safety

implications, where the professional is

pursuing a profession regulated Malta;

(l)

professionals

exercising

activities relating to the education of

minors, including in childcare and early

childhood

education,

where

the

professional is pursuing a profession

regulated in Malta.

(2) The National Commission for

Further and Higher Education shall send the

information referred to in sub-regulation (1) by

way of alert via IMI at the latest within three

days from the date of adoption of the decision

restricting or prohibiting pursuit of the

professional activity in its entirety or in part by

the professional concerned. That information

shall be limited to the following

(a)

the

identity

of

the

professional;

(b) the profession concerned;

(c)

information

about

the

authority or court adopting the decision

on restriction or prohibition;

(d) the scope of the restriction or

the prohibition; and

(e)

the period during which the

restriction or the prohibition applies.

(3) The National Commission for

Further and Higher Education shall, at the

latest within three days from the date of

adoption of the court decision, inform the

competent authorities of all other Member

States, by way of alert via IMI, about the

identity of professionals who have applied for

the recognition of a qualification and who have

subsequently been found by courts to have

used falsified evidence of professional

qualifications in this context.

(4) The processing of personal data for

the purpose of the exchange of information

referred to in sub-regulations (1) and (3) shall

be carried out in accordance with Directives

95/46/EC and 2002/58/EC.

(5) The National Commission for

Further and Higher Education shall inform the

competent authorities of all Member States

without delay when a prohibition or a

restriction referred to in sub-regulation (1) has

expired. For that purpose, the National

Commission for Further and Higher Education,

when providing the information in accordance

with sub-regulation (1), shall also be required

to provide the date of expiry as well as any

subsequent change to that date.

(6) Designated

authorities

shall

forthwith provide the National Commission for

Further and Higher Education with all

information required in terms of this regulation

for the purposes of permitting the National

Commission for Further and Higher Education

to meet its obligations in terms of this

regulation.

(7) The National Commission for

Further and Higher Education shall ensure that

professionals, in respect of whom alerts are

sent to other Member States, are informed in

writing of decisions on alerts at the same time

as the alert itself. Professionals may appeal, in

terms of article 7 of the Act, against the

decision to issue an alert or apply for

rectification of such decisions, and in such

cases the decision on the alert shall be

qualified to indicate that it is subject to

proceedings by the professional.

(8) Data regarding alerts may be

processed within IMI for as long as they are

valid. Alerts shall be deleted within three days

from the date of adoption of the revoking

decision or from the expiry of the prohibition

or the restriction referred to in sub-regulation

(1).

(9) Notwithstanding anything provided

in this regulation, the Minister may by notice

in the Gazette appoint any entity other than the

National Commission for Further and Higher

Education to perform the duties and

obligations set forth in this regulation, either in

addition to or in substitution of the National

Commission for Further and Higher

Education.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 5A of the principal

regulations, there shall be added the following new regulation

" Requirements,

5B. (1) Designated authorities shall

procedures and

ensure that all requirements, procedures and

formalities to be

formalities relating to matters covered by these

easily

completed,

regulations may be easily completed, remotely

remotely and by

electronic

and by electronic means. Designated

means.

authorities shall be permitted to request

certified copies at a later stage in the event of

justified doubts and where strictly necessary

Provided that this shall not apply to

the carrying out of an adaptation period or an

aptitude test.

(2) Where it is justified for a designated

authority to ask for advanced electronic

signatures, as defined in point 2 of Article 2 of

Directive 1999/93/EC, for the completion of

procedures referred to in sub-regulation (1),

the designated authority shall accept electronic

signatures in compliance with Commission

Decision 2009/767/EC of 16 October 2009 and

provide for technical means to process

documents with advanced electronic signature

in formats defined by Commission Decision

2011/130/EU of 25 February 2011.

(3) All procedures shall be carried out

in accordance with article 4(d) of the Services

(Internal Market) Act relating to the point of

single contact. The procedural time limits set

out in regulations 9(4) and 25 of these

regulations shall commence at the point when

an application or any missing document has

been submitted by a citizen to the point of

single contact or directly to the relevant

designated authority. Any request for certified

copies referred to in sub-regulation (1) shall

not be considered as a request for missing

documents.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 6 of the principal regulations shall be Substitutes

regulation 6 of

substituted by the following

the principal

regulations.

" National

6. (1) There shall be a National

Assistance

Assistance Centre whose remit shall be to

Centre.

provide citizens, as well as assistance centres

of the other Member States, with assistance

concerning the recognition of professional

qualifications provided for in these regulations

and

Directive

2005/36/EC,

including

information on the national legislation

governing the professions and the pursuit of

those professions, social legislation, and,

where appropriate, the rules of ethics.

(2) The National Assistance Centre

shall assist citizens in exercising the rights

conferred on them by these regulations, in

cooperation, where appropriate, with the

assistance centres of other Member States and

the designated authorities and the point of

single contact in Malta.

(3) Designated authorities shall fully

cooperate with the National Assistance Centre

and where appropriate national assistance

centres of other Member States, and provide all

relevant information about individual cases to

such assistance centres upon their request and

subject to data protection rules in accordance

with Directives 95/46/EC and 2002/58/EC.

(4) At the European Commission’s

request, the National Assistance Centre shall

inform the European Commission of the result

of enquiries which it is dealing with within two

months after receiving such a request.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 6 of the principal regulations,

Adds new

regulation to the

there shall be added the following new regulation

principal

regulations.

" Issuance of

6A. (1) Subject to the European

European

Commission having adopted implementing

Professional

acts as specified in Directive 2005/36/EC,

Card.

designated authorities shall issue holders of a

professional qualification with a European

Professional Card upon their request.

(2) When a European Professional Card

has been introduced for a particular profession

by means of relevant implementing acts

referred to in sub-regulation (1), the holder of a

professional qualification concerned may

choose to apply for such a European

Professional Card or to make use of the

procedures provided for in Titles II and III of

Directive 2005/36/EC.

(3) A holder of a European Professional

Card shall benefit from all the rights conferred

by regulations 6B to 6E.

(4) Where the holder of a professional

qualification intends to provide services under

Title II of Directive 2005/36/EC other than

those covered by Article 7(4) of the same

Directive, the relevant designated authority

shall issue the European Professional Card in

accordance with regulations 6B and 6C.

(5) Designated authorities shall also, in

cases when Malta is the host Member State,

recognise a European Professional Card as a

declaration under regulation 9.

(6) Where the holder of a professional

qualification intends to establish himself in

another Member State under Chapters I to IIIa

of Title III of Directive 2005/36/EC or to

provide services under Article 7(4) of

Directive 2005/36/EC, the relevant designated

authority shall complete all preparatory steps

with regard to the individual file of the

applicant created within the Internal Market

Information System (IMI) (IMI file) as

provided for in regulations 6B and 6D. The

relevant designated authority shall issue the

European Professional Card in accordance

with regulations 6B and 6D. For the purpose of

establishment in Malta, a European

Professional Card shall not provide an

automatic right to practise a particular

profession

if

there

are

registration

requirements or other control procedures

already in place in the Malta before a European

Professional Card is introduced for that

profession.

(7) The relevant designated authority

shall be responsible for dealing with IMI files

and issuing European Professional Cards. The

relevant designated authority shall ensure an

impartial, objective and timely processing of

applications for European Professional Cards.

Designated authorities and the National

Assistance Centre shall inform citizens,

including prospective applicants, about the

functioning and the added value of a European

Professional Card for the professions for which

it is available.

(8) Designated authorities may charge

fees to issue a European Professional Card,

provided such fees shall be reasonable,

proportionate and commensurate with the costs

incurred by the designated authority and shall

not act as a disincentive to apply for a

European Professional Card.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately

after

regulation

6A

of

the

principal Adds new

regulation to the

principal

regulations.

regulations, there shall be added the following new regulation

" On-line

6B. (1) In cases where Malta is the

application.

home Member State, the relevant designated

authority shall enable a holder of a professional

qualification to apply for a European

Professional Card through an on-line tool that

automatically creates an IMI file for the

particular applicant. Written applications shall

not be permitted.

(2) Applications shall be supported by

the documents specified in implementing acts

to be adopted by the European Commission

pursuant to Directive 2005/36/EC.

(3) Within one week of receipt of the

application, the relevant designated authority

shall acknowledge receipt of the application

and inform the applicant of any missing

document. Where applicable, the designated

authority shall issue any supporting certificate

required under these regulations. The

designated authority shall verify whether the

applicant is legally established in Malta and

whether all the necessary documents which

have been issued in Malta are valid and

authentic. In the event of duly justified doubts,

the designated authority shall consult the

relevant body and may request from the

applicant certified copies of documents. In

case of subsequent applications by the same

applicant, the designated authority may not

request the re-submission of documents which

are already contained in the IMI file and which

are still valid.

(4) In cases where Malta is the host

Member State, the designated authority may

not request the re-submission of documents

which are already contained in the IMI file and

which are still valid.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately

after

regulation

6B

of

the

principal

Adds new

regulation to the

principal

regulations.

regulations, there shall be added the following new regulation

" Verification of

6C. (1) In cases where Malta is the

application.

home Member State, the relevant designated

authority shall verify the application and the

supporting documents in the IMI file and issue

the European Professional Card for the

temporary and occasional provision of services

other than those covered by Article 7(4) of

Directive 2005/36/EC within three weeks. That

time period shall start upon receipt of the

missing documents referred to in sub-

regulation (3) of regulation 6B or, if no further

documents were requested, upon the expiry of

the one-week period referred to in that sub-

regulation. The relevant designated authority

shall then transmit the European Professional

Card immediately to the competent authority

of each host Member State concerned and shall

inform the applicant accordingly.

(2) In cases where Malta is the host

Member State, the relevant designated

authority may not require any further

declaration under regulation 9 for the

following eighteen months.

(3) The decision of the relevant

designated authority or the absence of a

decision within the period of three weeks

referred to in sub-regulation (1) shall be

subject to appeal in terms of article 7 of the

Act.

(4) If a holder of a European

Professional Card wishes to provide services in

Member States other than those initially

mentioned in the application referred to in sub-

regulation (1), that holder may apply for such

extension. If the holder wishes to continue

providing services beyond the period of

eighteen months referred to in sub-regulation

(1), that holder shall inform the relevant

designated authority accordingly. In either

case, that holder shall also provide any

information on material changes in the

situation substantiated in the IMI file that may

be required by the relevant designated

authority in accordance with the implementing

acts to be adopted by the European

Commission. The designated authority shall

transmit the updated European Professional

Card to the host Member States concerned.

(5) A European Professional Card

issued by a competent authority of another

Member State shall be valid in the entire

territory of Malta for as long as its holder

maintains the right to practice on the basis of

the documents and information contained in

the IMI file.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 6C of the principal

regulations, there shall be added the following new regulation

" Verification of

6D. (1) In cases where Malta is the

authenticity and

home Member State, the relevant designated

validity of

authority shall, within one month, verify the

supporting

documents.

authenticity and validity of the supporting

documents in the IMI file for the purpose of

issuing a European Professional Card for

establishment or for the temporary and

occasional provision of services under Article

7(4) of Directive 2005/36/EC. That time period

shall start upon receipt of the missing

documents referred to in sub-regulation (3) of

regulation 6B or, if no further documents were

requested, upon the expiry of the one-week

period referred to in that sub-regulation. It

shall then transmit the application immediately

to the competent authority of the host Member

State. The relevant designated authority shall

inform the applicant of the status of the

application at the same time as it transmits the

application to the host Member State.

(2) In cases where Malta is the host

Member State, in the instances referred to in

regulations 18, 22(1), 29 and 30, the relevant

designated authority shall decide whether to

issue a European Professional Card under sub-

regulation (1) within one month of receipt of

the application transmitted by the home

Member State. In the event of duly justified

doubts, the relevant designated authority may

request additional information from, or the

inclusion of a certified copy of a document by,

the home Member State, which the latter shall

provide no later than two weeks after the

submission of the request. Subject to the

provisions of sub-regulation (5), the period of

one month shall apply, notwithstanding any

such request

Provided that, in cases where Malta

is the home Member State, upon receipt of a

request for additional information or the

inclusion of a certified copy of a document

from the host Member State, the relevant

designated authority shall provide the same

within no later than two weeks after the

submission of the request.

(3) In cases where Malta is the host

Member State, in the instances referred to in

regulations 9(4) and 16, the relevant

designated authority shall decide whether to

issue a European Professional Card or to

subject the holder of a professional

qualification to compensation measures within

two months of receipt of the application

transmitted by the home Member State. In the

event of duly justified doubts, the relevant

designated authority may request additional

information from, or the inclusion of a certified

copy of a document by, the home Member

State which the latter shall provide no later

than two weeks after the submission of the

request. Subject to the provisions of sub-

regulation (5), the period of two months shall

apply, notwithstanding any such request

Provided that, in cases where Malta

is the home Member State, upon receipt of a

request for additional information or the

inclusion of a document from the host Member

State, the relevant designated authority shall

provide the same within no later than two

weeks after the submission of the request.

(4) In cases where Malta is the host

Member State, in the event that the relevant

designated authority does not receive the

necessary information which it may require in

accordance with these regulations for taking a

decision on the issuance of the European

Professional Card from either the home

Member State or the applicant, it may refuse to

issue the Card. Such refusal shall be duly

justified.

(5) In cases where Malta is the host

Member State, where the relevant designated

authority fails to take a decision within the

time limits set out in sub-regulations (2) and

(3) or fails to organise an aptitude test in

accordance with regulation 9(4), the European

Professional Card shall be deemed to be issued

and shall be sent automatically, through IMI, to

the holder of a professional qualification.

The relevant designated authority

shall have the possibility to extend by two

weeks the deadlines set out in sub-regulations

(2) and (3) for the automatic issuance of the

European Professional Card. It shall explain

the reason for the extension and inform the

applicant accordingly. Such an extension may

be repeated once and only where it is strictly

necessary, in particular for reasons relating to

public health or the safety of the service

recipients.

(6) In cases where Malta is the host

Member State, the actions taken by the home

Member State in accordance with sub-

regulation (1) shall replace any application for

recognition of professional qualifications

under the national law of Malta.

(7) The decisions of a designated

authority under sub-regulations (1) to (5) or the

absence of decision shall be subject to appeal

in accordance with article 7 of the Act.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 6D of the principal Adds new

regulation to the

regulations, there shall be added the following new regulation

principal

regulations.

" Updating of

6E. (1) Without prejudice to the

IMI file.

presumption of innocence, the relevant

designated authority shall update, in a timely

manner, the corresponding IMI file with

information regarding disciplinary actions or

criminal sanctions which relate to a prohibition

or restriction and which have consequences for

the pursuit of activities by the holder of a

European Professional Card under these

regulations or Directive 2005/36/EC. In so

doing they shall respect personal data

protection rules provided for in Directive 95/

46/EC and Directive 2002/58/EC. Such

updates shall include the deletion of

information which is no longer required. The

holder of the European Professional Card as

well as the relevant designated authorities that

have access to the corresponding IMI file shall

be informed immediately of any updates. This

obligation shall be without prejudice to the

alert obligations set forth in regulation 5A.

(2) The content of the information

updates referred to in sub-regulation (1) shall

be limited to the following

(a)

the

identity

of

the

professional;

(b) the profession concerned;

(c)

information

about

the

national authority or court which has

adopted the decision on restriction or

prohibition;

(d) the scope of the restriction or

the prohibition; and

(e)

the period for which the

restriction or the prohibition applies.

(3) Access to the information in the IMI

file shall be limited to the relevant designated

authority, in accordance with Directive 95/46/

EC. The relevant designated authority shall

inform the holder of the European Professional

Card of the content of the IMI file upon that

holder’s request.

(4) The information included in the

European Professional Card shall be limited to

the information that is necessary to ascertain

its holder’s right to exercise the profession for

which it has been issued, namely the holder’s

name, surname, date and place of birth,

profession, formal qualifications, and the

applicable regime, designated or competent

authorities involved, Card number, security

features and reference to a valid proof of

identity. Information relating to professional

experience

acquired,

or

compensation

measures passed, by the holder of the European

Professional Card shall be included in the IMI

file.

(5) The personal data included in the

IMI file may be processed for as long as it is

needed for the purpose of the recognition

procedure as such and as evidence of the

recognition or of the transmission of the

declaration required under Article 7 of

Directive 2005/36/EC or regulation 9. The

holder of a European Professional Card shall

have the right at any time, and at no cost to that

holder, to request the rectification of inaccurate

or incomplete data, or the deletion or blocking

of the IMI file concerned. The holder shall be

informed of this right at the time the European

Professional Card is issued, and reminded of it

every two years thereafter. The reminder shall

be sent automatically via IMI where the initial

application for the European Professional Card

was submitted online.

In the event of a request for deletion

of an IMI file linked to a European

Professional Card issued for the purpose of

establishment or temporary and occasional

provision of services under Article 7(4) of

Directive 2005/36/EC or regulation 9(4), the

designated authority shall issue the holder of

professional qualifications with evidence

attesting to the recognition of his professional

qualifications.

(6) In relation to the processing of

personal data in the European Professional

Card and all IMI files, the relevant designated

authority shall be regarded as a controller

within the meaning of point (d) of Article 2 of

Directive 95/46/EC.

(7) Without prejudice to sub-regulation

(3), designated authorities shall permit

employers, customers, patients, public

authorities and other interested parties to verify

the authenticity and validity of a European

Professional Card presented to them by the

Card holder.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 6E of the principal

regulations, there shall be added the following new regulation

" Partial access

6F. (1) Designated authorities shall

to a professional

grant partial access, on a case-by-case basis, to

activity.

a professional activity only when all the

following conditions are fulfilled

(a)

the professional is fully

qualified to exercise in the home Member

State the professional activity for which

partial access is sought in Malta;

(b) differences

between

the

professional activity legally exercised in

the home Member State and the regulated

profession in Malta as such are so large

that the application of compensation

measures would amount to requiring the

applicant to complete the full programme

of education and training required in

Malta to have access to the full regulated

profession in Malta;

(c)

the professional activity can

objectively be separated from other

activities falling under the regulated

profession in Malta; provided that for this

purpose the designated authority shall

take

into

account

whether

the

professional activity can be pursued

autonomously in Malta.

(2) Partial access may be rejected if

such rejection is justified by overriding reasons

of general interest, suitable for securing the

attainment of the objective pursued, and does

not go beyond what is necessary to attain that

objective.

(3) Applications for the purpose of

establishment in Malta shall be examined in

accordance with Sections I and III of Part III of

these regulations.

(4) Applications for the purpose of

providing temporary and occasional services in

Malta concerning professional activities that

have public health or safety implications shall

be examined in accordance with Part II of these

regulations.

(5) Notwithstanding the provisions of

regulations 9(4) and 27, the professional

activity shall be exercised under the

professional title of the home Member State

once partial access has been granted. The

designated authority may require use of that

professional title in the languages of Malta.

Professionals benefiting from partial access

shall clearly indicate to the service recipients

the scope of their professional activities.

(6) This regulation shall not apply to

professionals benefiting from automatic

recognition of their professional qualifications

under Chapters II, III and IIIa of Title III of

Directive 2005/36/EC.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Paragraph (b) of sub-regulation (1) of regulation 7 of the Amends

regulation 7 of

principal regulations shall be substituted by the following

the principal

regulations.

"(b) where the service provider moves, if he has pursued

that profession in one or several Member States for at least one

year during the last ten years preceding the provision of services

when the profession is not regulated in the Member State of

establishment. The condition of one year’s pursuit shall not

apply if the profession or the education and training leading to

the profession is regulated.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 9 of the principal regulations shall be amended Amends

regulation 9 of

as follows

the principal

regulations.

(a)

in paragraph (d) of sub-regulation (2) thereof, for

the words "two years" there shall be substituted the words "one

year";

(b) for paragraph (e) of sub-regulation (2) thereof there

shall be substituted the following

"(e) for professions in the security sector, in the

health sector and professions related to the education of

minors, including in childcare and early childhood

education, where required for Maltese nationals, an

attestation confirming the absence of temporary or final

suspensions from exercising the profession or of criminal

convictions;";

(c)

immediately after paragraph (e) of sub-regulation

(2) thereof there shall be added the following new paragraphs

"(f) for professions that have patient safety

implications, a declaration about the applicant’s

knowledge of the language necessary for practising the

profession in Malta;

(g) for professions covering the activities

referred to in regulation 18 and which were notified to the

European Commission in accordance with Directive 2005/

36/EC, a certificate concerning the nature and duration of

the activity issued by the competent authority or body of

the Member State where the service provider is

established.";

(d) for paragraph (b) of sub-regulation (4) thereof there

shall be substituted the following

"(b) No later than one month after receipt of the

declaration and accompanying documents, the designated

authority shall inform the service provider of its decision

(i) not

to

check

his

professional

qualifications; or

(ii) having checked his professional

qualifications, to either require the service provider

to take an aptitude test or allow the service

provider to provide the services.

Where there is a difficulty which would result in

delay in taking a decision under sub-paragraph (ii), the

designated authority shall notify the service provider of the

reason for the delay within the same deadline. The

difficulty shall be solved within one month of that

notification and the decision finalised within two months

of resolution of the difficulty.";

(e)

for paragraph (c) of sub-regulation (4) thereof there

shall be substituted the following

"(c) Where there is a substantial difference

between the professional qualifications of the service

provider and the training required in the Malta, to the

extent that that difference is such as to be harmful to public

health or safety, and that it cannot be compensated by the

service provider’s professional experience or by

knowledge, skills and competences acquired through

lifelong learning formally validated to that end by a

relevant body, the designated authority shall give that

service provider the opportunity to show, by means of an

aptitude test, that he has acquired the knowledge, skills or

competence that were lacking. The designated authority

shall take a decision on that basis on whether to allow the

provision of services. In any case, it must be possible to

provide the service within one month of the decision taken

in accordance with paragraph (b)(ii)."; and

(f) immediately after sub-regulation (4) thereof there

shall be added the following new sub-regulation

"(5) Submission of a required declaration by the

service provider in accordance with sub-regulation (1)

shall entitle that service provider to have access to the

service activity or to exercise that activity in the entire

territory of Malta; provided that a designated authority

may require additional information listed in sub-regulation

(2) concerning the professional qualifications of the

service provider if

(a) the profession is regulated in parts of the

territory of Malta in a different manner;

(b) such regulation is applicable also to all

nationals of Malta;

(c) the differences in such regulation are

justified by overriding reasons of general interest

relating to public health or safety of service

recipients; and

(d) the designated authority has no other

means of obtaining such information.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Sub-regulation (1) of regulation 10 of the principal

regulations shall be substituted by the following

"(1) Designated authorities may ask the competent

authorities of the Member State of establishment, in the event of

justified doubts, to provide any information relevant to the

legality of the service provider’s establishment and good

conduct, as well as the absence of any disciplinary or criminal

sanctions of a professional nature. In the event that the

designated authorities decide to check the service provider’s

professional qualifications, they may ask the competent

authorities of the Member State of establishment for

information about the service provider’s training courses to the

extent necessary to assess substantial differences likely to be

harmful to public health or safety.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

In paragraph (a) of regulation 12 of the principal

regulations, for the words "Schedule IV" there shall be substituted the

words "Schedule II".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 13 of the principal regulations shall be

amended as follows

(a)

for the words "regulation 12" there shall be

substituted the words "regulations 12 and 16";

(b) for sub-paragraph (ii) of paragraph (c) thereof there

shall be substituted the following

"(ii) regulated education and training or, in the

case of regulated professions, vocational training with a

special structure, with competences going beyond what is

provided for in paragraph (b), equivalent to the level of

training provided for under sub-paragraph (i), if such

training provides a comparable professional standard and

prepares the trainee for a comparable level of

responsibilities and functions provided that the diploma is

accompanied by a certificate from the home Member

State;"

(c)

for paragraph (d) thereof there shall be substituted

the following

"(d) a diploma certifying that the holder has

successfully completed training at post-secondary level of

at least three and not more than four years’ duration, or of

an equivalent duration on a part-time basis, which may in

addition be expressed with an equivalent number of ECTS

credits, at a university or establishment of higher education

or another establishment of equivalent level and, where

appropriate, that he has successfully completed the

professional training required in addition to the post-

secondary course;"; and

(d) for paragraph (e) thereof there shall be substituted

the following

"(e) a diploma certifying that the holder has

successfully completed a post-secondary course of at least

four years’ duration, or of an equivalent duration on a part-

time basis, which may in addition be expressed with an

equivalent number of ECTS credits, at a university or

establishment of higher education or another establishment

of equivalent level and, where appropriate, that he has

successfully completed the professional training required

in addition to the post- secondary course.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

In sub-regulation (1) of regulation 14 of the principal Amends

regulations for the words "certifying completion of training in the regulation

the principal

Member States" there shall be substituted the words "certifying regulations.

completion of training in the Member States, on a full or part-time

basis, within or outside formal programmes".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 15 of the principal regulations shall be Substitutes

regulation 15 of

substituted by the following

the principal

regulations.

"15. (1) If access to or pursuit of a regulated profession

in Malta is contingent upon possession of specific professional

qualifications, the relative designated authority shall permit

applicants to access and pursue that profession, under the same

conditions as apply to its nationals, if they possess an attestation

of competence or evidence of formal qualifications referred to

in regulation 13, required by another Member State in order to

gain access to and pursue that profession on its territory

Provided that the attestations of competence or

evidence of formal qualifications must satisfy the condition of

having been issued by a competent authority in a Member State,

designated in accordance with the laws, regulations or

administrative provisions of that Member State.

(2) Access to, and pursuit of, a profession as described

in sub-regulation (1) shall also be granted to applicants who

have pursued the profession in question on a full-time basis for

one year or for an equivalent overall duration on a part-time

basis during the previous ten years in another Member State

which does not regulate that profession, and who possess one or

more attestations of competence or evidence of formal

qualifications issued by another Member State which does not

regulate the profession. Attestations of competence and

evidence of formal qualifications shall satisfy the following

conditions

(a) they shall have been issued by the competent

authority in a Member State, designated in accordance

with the legislative, regulatory or administrative provisions

of that Member State;

(b) they shall attest that the holder has been

prepared for the pursuit of the profession in question.

(3) The one year of professional experience referred to

in sub-regulation (2) may not, however, be required if the

evidence of formal qualifications which the applicant possesses

certifies regulated education and training.

(4) Designated authorities shall accept the level attested

under regulation 13 by the home Member State, as well as the

certificate by which the home Member State certifies that

regulated education and training or vocational training with a

special structure referred to in regulation 13(c)(ii) is equivalent

to the level provided for in regulation 13(c)(i).

(5) Notwithstanding the provisions of sub-regulations

(1) and (2) and regulation 16, a designated authority may refuse

access to, and pursuit of, the profession to holders of an

attestation of competence classified under regulation 13(a)

where the professional qualification required to exercise the

profession in Malta is classified under regulation 13(e).".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 16 of the principal regulations shall be

amended as follows

(a)

paragraph (a) of sub-regulation (1) thereof shall be

deleted;

(b) paragraph (b) of sub-regulation (1) thereof shall be

re-numbered as paragraph (a);

(c)

paragraph (c) of sub-regulation (1) thereof shall be

re-numbered as paragraph (b) and shall be substituted by the

following

"(b) the regulated profession comprises one or

more regulated professional activities which do not exist in

the corresponding profession in the applicant’s home

Member State, and the training required in Malta covers

substantially different matters from those covered by the

applicant’s attestation of competence or evidence of formal

qualifications.";

(d) sub-regulation (5) thereof shall be substituted by the

following

"(5) By way of derogation from the principle of

the right of the applicant to choose, as laid down in sub-

regulation (2), the designated authority may stipulate either

an adaptation period or an aptitude test in the case of

(a)

a holder of a professional qualification

referred to in regulation 13(a), who applies for

recognition of his professional qualifications where

the national professional qualification required is

classified under regulation 13(c); or

(b)

a holder of a professional qualification

referred to in regulation 13(b), who applies for

recognition of his professional qualifications where

the national professional qualification required is

classified under regulation 13(d) or (e).

In the case of a holder of a professional

qualification referred to in regulation 13(a) who applies for

recognition of his professional qualifications where the

national professional qualification required is classified

under regulation 13(d), the designated authority may

impose both an adaptation period and an aptitude test.";

and

(e)

immediately after sub-regulation (5) thereof there

shall be added the following new sub-regulations

"(6) Sub-regulation (1) shall be applied with due

regard to the principle of proportionality. In particular, if

the designated authority intends to require the applicant to

complete an adaptation period or take an aptitude test, it

must first ascertain whether the knowledge, skills and

competences acquired by the applicant in the course of his

professional experience or through lifelong learning, and

formally validated to that end by a relevant body, in any

Member State or in a third country, is of such nature as to

cover, in full or in part, substantially different matters.

(7) The decision imposing an adaptation period

or an aptitude test shall be duly justified. In particular, the

applicant shall be provided with the following information

(a)

the level of the professional

qualification required by the designated authority

and the level of the professional qualification held

by the applicant in accordance with the

classification set out in regulation 13; and

(b) the substantially different matters and

the reasons for which those differences cannot be

compensated

by

knowledge,

skills

and

competences acquired in the course of professional

experience or through lifelong learning formally

validated to that end by a relevant body.

(8) Designated authorities shall ensure that an

applicant has the possibility of taking the aptitude test

referred to in sub-regulation (1) not later than six months

after the initial decision imposing an aptitude test on the

applicant.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 17 of the principal regulations shall be deleted.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

In regulation 18 of the principal regulations, for the words

"Schedule IV" there shall be substituted the words "Schedule II".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 19 of the principal regulations shall be

amended as follows

(a)

in sub-regulation (1) thereof, for the words

"Schedule IV" there shall be substituted the words "Schedule

II"; and

(b) in the Maltese version of paragraph (a) of sub-

regulation (1) thereof, the words "jew attivitajiet elenkati fil-

Lista I, Skeda IV;" shall be deleted; and

(c)

in sub-regulation (3) thereof, for the words

"Schedule IV" there shall be substituted the words "Schedule

II".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

In sub-regulation (1) of regulation 20 of the principal Amends

regulations, for the words "Schedule IV" there shall be substituted the regulation

the principal

words "Schedule II".

regulations.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

In sub-regulation (1) of regulation 21 of the principal Amends

regulations, for the words "Schedule IV" there shall be substituted the regulation

the principal

words "Schedule II".

regulations.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Paragraph (b) of sub-regulation (2) of regulation 22 of the Amends

regulation 22 of

principal regulations shall be substituted by the following

the principal

regulations.

"(b) designated authorities shall ensure, by encouraging

continuous professional development, that professionals whose

professional qualification is covered by Section III of Part III of

these regulations are able to update their knowledge, skills and

competences in order to maintain a safe and effective practice

and keep abreast of professional developments.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 22 of the principal Adds new

regulation to the

regulations there shall be added the following new regulation

principal

regulations.

" Notification to

22A. (1) The designated authorities

the Commission.

responsible for the professions referred to in

regulation 22(1) shall notify the Commission

of the laws, regulations and administrative

provisions which are adopted with regard to

the issuing of evidence of formal qualifications

in relation to the professions referred to in

regulation 22(1). In the case of evidence of

formal qualifications referred to in the Periti

Act and Mutual Recognition of Qualifications

of Perit Regulations, notification shall also be

addressed to the other Member States.

(2) The notification referred to in sub-

regulation (1) shall include information about

the duration and content of the training

programmes and shall be transmitted via IMI.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 24 of the principal regulations shall be Amends

regulation 24 of

amended as follows

the principal

regulations.

(a)

in sub-regulation (1) thereof, for the words

"Schedule V" there shall be substituted the words "Schedule

III";

(b)

in sub-regulation (2) thereof, for the words

"Schedule V" there shall be substituted the words "Schedule

III";

(c)

sub-regulations (4) and (5) thereof shall be

renumbered as sub-regulations (6) and (7) respectively; and

(d) immediately after sub-regulation (3) thereof there

shall be added the following new sub-regulations

"(4) In the event of justified doubts, the

designated authorities may require from the competent

authorities of a Member State confirmation of the fact that

the applicant is not suspended or prohibited from the

pursuit of the profession as a result of serious professional

misconduct or conviction of criminal offences relating to

the pursuit of any of his professional activities.

(5) Exchange of information between designated

authorities and competent authorities of different Member

States under this regulation shall take place by means of

the IMI.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 28 of the principal

regulations, there shall be added the following new regulation

" Common

29. (1) For the purpose of this

training

regulation, "common training framework"

framework.

means a common set of minimum knowledge,

skills and competences necessary for the

pursuit of a specific profession. A common

training framework shall not replace national

training programmes unless otherwise stated

by law. For the purpose of access to and pursuit

of a profession in Malta which is regulated, the

designated authorities shall give evidence of

professional qualifications acquired on the

basis of such a framework the same effect in

Malta as the evidence of formal qualifications

which are issued by competent authorities in

Malta, on condition that such framework is

adopted by means of a delegated act issued by

the European Commission in terms of

Directive 2005/36/EC.

(2) In the event that the European

Commission establishes a common training

framework for a given profession by means of

a delegated act adopted in accordance with

Directive 2005/36/EC, the designated authority

responsible for that profession shall be

exempted from the obligation of introducing

the common training framework and from the

obligation of granting automatic recognition to

the professional qualifications acquired under

that common training framework if one of the

following conditions is fulfilled

(a)

there are no education or

training institutions available in Malta to

offer such training for the profession

concerned;

(b) the introduction of the

common training framework would

adversely affect the organisation of the

system of education and professional

training in Malta;

(c)

there

are

substantial

differences between the common training

framework and the training required in

Malta, which entail serious risks for

public policy, public security, public

health or for the safety of the service

recipients or the protection of the

environment.

(3) The relevant designated authority

shall, within six months of the entry into force

of the delegated act referred to in sub-

regulation (2), notify to the Commission and to

the other Member States

(a)

the national qualifications,

and where applicable the national

professional titles, that comply with the

common training framework; or

(b) any use of the exemption

referred to in sub-regulation (2), along

with a justification of which conditions

under sub-regulation were fulfilled. In

the event that the Commission requests

further clarification, the designated

authority shall reply within three months

of any such request.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 29 of the principal

regulations, there shall be added the following new regulation

" Common

30. (1) For the purpose of this

training test.

regulation, a "common training test" means a

standardised aptitude test available across

participating Member States and reserved to

holders

of

a

particular

professional

qualification. Passing such a test in a Member

State shall entitle the holder of a particular

professional qualification to pursue the

profession in Malta under the same conditions

as the holders of professional qualifications in

Malta.

(2) In the event that the European

Commission establishes a common training

test for a given profession by means of a

delegated act adopted in accordance with

Directive 2005/36/EC, the designated authority

responsible for that profession shall be

exempted from the obligation of organising the

common training test in Malta and from the

obligation of granting automatic recognition to

professionals who have passed the common

training test if one of the following conditions

is fulfilled

(a)

the profession concerned is

not regulated in Malta;

(b) the contents of the common

training test will not sufficiently mitigate

serious risks for public health or the

safety of the service recipients, which are

relevant in Malta;

(c)

the contents of the common

training test would render access to the

profession significantly less attractive

compared to national requirements.

(3) The relevant designated authority

shall, within six months of the entry into force

of the delegated act referred to in sub-

regulation (2), notify to the Commission and to

the other Member States

(a)

the available capacity for

organising such tests; or

(b) any use of the exemption

referred to in sub-regulation (2), along

with the justification of which conditions

under that sub-regulation were fulfilled.

In the event that the Commission requests

further clarification, the designated

authority shall reply within three months

of any such request.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 30 of the principal Adds new

regulation to the

regulations, there shall be added the following new regulation

principal

regulations.

" Professional

31. (1) If access to a regulated

traineeship.

profession in Malta is contingent upon

completion of a professional traineeship, the

relevant designated authority shall, when

considering a request for authorisation to

exercise the regulated profession, recognise

professional traineeships carried out in another

Member State provided the traineeship is in

accordance with the published guidelines

referred to in sub-regulation (2), and shall take

into account professional traineeships carried

out in a third country, subject to any reasonable

limits, established by national law, on the

duration of the part of the professional

traineeship which can be carried out abroad.

(2) Recognition of the professional

traineeship shall not replace any requirements

in place to pass an examination in order to gain

access to the profession in question. The

designated authorities shall publish guidelines

on the organisation and recognition of

professional traineeships carried out in another

Member State or in a third country, in

particular on the role of the supervisor of the

professional traineeship.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Schedules II and III to the principal regulations shall be

deleted, and Schedules IV and V shall be renumbered as Schedules II

and III respectively.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after paragraph (f) of point 1 of Schedule III,

as renumbered, to the principal regulations, there shall be added the

following

"(g) Where the designated authority so requires for its

own nationals, an attestation confirming the absence of

temporary or final suspensions from exercising the profession

or of criminal convictions.".

Part V

Amendments to the Minimum Training Conditions

(Health Care Professions) Regulations

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

(1) This Part amends the Recognition of Minimum

Training Conditions (Health Care Professions) Regulations and it

shall be read and construed as one with the Minimum Training

Conditions (Health Care Professions) Regulations, hereinafter in this

Part referred to as "the principal regulations".

(2) The regulations included in this Part implement certain

provisions of Commission Directive 2013/55/EU, and they are made

by virtue of the powers conferred on the Minister for Education and

Employment by article 38 of the Various Laws (Transposition of

Directive 2013/55/EU) (Amendment) Act, 2016, and article 8 of the

Mutual Recognition of Qualifications Act.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 2 of the principal regulations shall be amended

as follows

(a)

the present regulation shall be re-numbered as sub-

regulation (1) thereof, and shall be substituted by the following

"(1) These regulations transpose Articles 24, 25,

31, 34, 35, 40 and 44 regarding basic and specialist

medical and dental training and the training of nurses

responsible for general care, midwives and pharmacists

and also Annex V 5.2.1, 5.3.1, 5.5.1 and 5.6.1 of Directive

2005/36/EC of the 7th September 2005 on the Recognition

of Professional Qualifications." ; and

(b) immediately after sub-regulation (1), as re-

numbered, thereof, there shall be added the following new sub-

regulation (2)

"(2) In these regulations, unless the context

otherwise requires

" "ECTS credits" means the credit system for

higher education used in the European Higher Education

Area.".".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 3 of the principal regulations shall be amended Amends

regulation 3 of

the principal

regulations.

(a)

for sub-regulation (1) thereof there shall be

substituted the following

"(1) Admission to training for nurses responsible

for general care shall be contingent upon either

(a) completion of general education of

twelve years, as attested by a diploma, certificate

or other evidence issued by the competent

authorities or bodies or a certificate attesting

success in an examination of an equivalent level

and giving access to universities or to higher

education institutions of a level recognised as

equivalent; or

(b) completion of general education of at

least ten years, as attested by a diploma, certificate

or other evidence issued by the competent

authorities or bodies or a certificate attesting

success in an examination of an equivalent level

and giving access to a vocational school or

vocational training programme for nursing.

Training of nurses responsible for general care

shall be given on a full-time basis and shall include at least

the programme described in the Schedule, Part 1.";

(b) for sub-regulation (2) thereof there shall be

substituted the following

"(2) The training of nurses responsible for general

care shall comprise a total of at least three years of study,

which may in addition be expressed with the equivalent

ECTS credits, and shall consist of at least 4 600 hours of

theoretical and clinical training, the duration of the

theoretical training representing at least one third and the

duration of the clinical training at least one half of the

minimum duration of the training. Partial exemptions may

be granted to professionals who have received part of their

training on courses which are of at least an equivalent

level.";

(c)

for sub-regulation (4) thereof there shall be

substituted the following

"(4) Theoretical education is that part of nurse

training from which trainee nurses acquire the professional

knowledge, skills and competences required under sub-

regulations (6) and (7). The training shall be given by

teachers of nursing care and by other competent persons, at

universities, higher education institutions of a level

recognised as equivalent or at vocational schools or

through vocational training programmes for nursing.";

(d) in sub-regulation (5) thereof for the words

"knowledge and skills" there shall be substituted the words

"knowledge, skills and competences";

(e)

for sub-regulation (6) thereof there shall be

substituted the following

"(6) Training for nurses responsible for general

care shall provide an assurance that the professional in

question has acquired the following knowledge and skills

(a) comprehensive knowledge of the

sciences on which general nursing is based,

including sufficient understanding of the structure,

physiological functions and behaviour of healthy

and sick persons, and of the relationship between

the state of health and the physical and social

environment of the human being;

(b) knowledge of the nature and ethics of

the profession and of the general principles of

health and nursing;

(c) adequate clinical experience; such

experience, which should be selected for its

training value, should be gained under the

supervision of qualified nursing staff and in places

where the number of qualified staff and equipment

are appropriate for the nursing care of the patient;

(d) the ability to participate in the practical

training of health personnel and experience of

working with such personnel; and

(e) experience of working together with

members of other professions in the health sector.";

and

(f)

immediately after sub-regulation (6) thereof, there

shall be added the following new sub-regulation (7)

"(7) Formal qualifications as a nurse responsible

for general care shall provide evidence that the

professional in question is able to apply at least the

following competences regardless of whether the training

took place at universities, higher education institutions of a

level recognised as equivalent or at vocational schools or

through vocational training programmes for nursing

(a) competence to independently diagnose

the nursing care required using current theoretical

and clinical knowledge and to plan, organise and

implement nursing care when treating patients on

the basis of the knowledge and skills acquired in

accordance with sub-regulation (6)(a), (b) and (c)

in order to improve professional practice;

(b) competence to work together effectively

with other actors in the health sector, including

participation in the practical training of health

personnel on the basis of the knowledge and skills

acquired in accordance with sub-regulation (6)(d)

and (e);

(c) competence to empower individuals,

families and groups towards healthy lifestyles and

self-care on the basis of the knowledge and skills

acquired in accordance with sub-regulation (6)(a)

and (b);

(d) competence to independently initiate

life preserving immediate measures and to carry

out measures in crises and disaster situations;

(e) competence to independently give

advice to, instruct and support persons needing

care and their attachment figures;

(f) competence to independently assure the

quality of, and to evaluate, nursing care;

(g) competence

to

comprehensively

communicate professionally and to cooperate with

members of other professions in the health sector;

(h) competence to analyse the care quality

to improve his own professional practice as a nurse

responsible for general care.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Sub-regulation (2) of regulation 4 of the principal

regulations shall be substituted by the following

"(2) Basic dental training shall comprise a total of at

least five years of study, which may in addition be expressed

with the equivalent ECTS credits, and shall consist of at least

5,000 hours of full-time theoretical and practical training that

comprises at least the programme described in Part 2 of the

Schedule and that is provided in a university, in a higher

institute providing training recognised as being of an equivalent

level or under the supervision of a university.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 5 of the principal regulations shall be amended

as follows

(a)

sub-regulation (1) thereof shall be substituted by the

following

"(1) Admission to specialist dental

training shall be contingent upon completion

and validation of basic dental training referred

to in regulation 4, or possession of the

documents referred to in regulation 23 of the

Recognition of Professional Qualifications

Regulations and in the Health Care Professions

Act."; and

(b) in sub-regulation (2) thereof for the word "It" there

shall be substituted the word "They".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 6 of the principal regulations shall be amended

as follows

(a)

for sub-regulation (3) thereof there shall be

substituted the following

"(3) Admission to training as a midwife

shall be contingent upon one of the following

conditions

(a) completion of at least

twelve years of general school

education or possession of a

certificate attesting success in an

examination, of an equivalent level,

for admission to a midwifery school

for Route I; or

(b) possession of evidence

of formal qualifications as a nurse

responsible for general care referred

to in Part V of the Second Schedule

to the Health Care Professions Act

for Route II."; and

(b) for sub-regulation (4) thereof there shall be

substituted the following

"(4) Training as a midwife shall provide an

assurance that the professional in question has acquired the

following knowledge and skills

(a) detailed knowledge of the sciences on

which the activities of midwives are based,

particularly

midwifery,

obstetrics

and

gynaecology;

(b) adequate knowledge of the ethics of the

profession and the legislation relevant for the

practice of the profession;

(c) adequate knowledge of general medical

knowledge (biological functions, anatomy and

physiology) and of pharmacology in the field of

obstetrics and of the newly born, and also

knowledge of the relationship between the state of

health and the physical and social environment of

the human being, and of his behaviour;

(d) adequate clinical experience gained in

approved institutions allowing the midwife to be

able, independently and under his own

responsibility, to the extent necessary and

excluding pathological situations, to manage the

antenatal care, to conduct the delivery and its

consequences in approved institutions, and to

supervise labour and birth, postnatal care and

neonatal resuscitation while awaiting a medical

practitioner;

(e) adequate understanding of the training

of health personnel and experience of working with

such personnel.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Sub-regulation (2) of regulation 7 of the principal

regulations shall be substituted by the following

"(2) Evidence of formal qualifications as a pharmacist

shall attest to training of at least five years’ duration, which may

in addition be expressed with the equivalent ECTS credits,

comprising at least

(a) four years of full-time theoretical and

practical training at a university or at a higher institute of a

level recognised as equivalent, or under the supervision of

a university;

(b) during or at the end of the theoretical and

practical training, six-month traineeship in a pharmacy

which is open to the public or in a hospital under the

supervision of that hospital’s pharmaceutical department.".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 7 of the principal regulations

there shall be added the following new regulation

" Admission to

8. (1) Admission to basic medical

basic medical

training shall be contingent upon possession of

a diploma or certificate providing access, for

the studies in question, to universities.

(2) Basic medical training shall

comprise a total of at least five years of study,

which may in addition be expressed with the

equivalent ECTS credits, and shall consist of at

least 5 500 hours of theoretical and practical

training provided by, or under the supervision

of, a university. For professionals who began

their studies before 1 January 1972, the course

of training referred to in sub-regulation (1)

may comprise six months of full-time practical

training at university level under the

supervision of the competent authorities.

(3) Basic medical training shall provide

an assurance that the person in question has

acquired the following knowledge and skills

(a)

adequate knowledge of the

sciences on which medicine is based and

a good understanding of the scientific

methods including the principles of

measuring biological functions, the

evaluation of scientifically established

facts and the analysis of data;

(b) sufficient understanding of

the structure, functions and behaviour of

healthy and sick persons, as well as

relations between the state of health and

physical and social surroundings of the

human being;

(c)

adequate

knowledge

of

clinical disciplines and practices,

providing him with a coherent picture of

mental and physical diseases, of

medicine from the points of view of

prophylaxis, diagnosis and therapy and of

human reproduction;

(d) suitable clinical experience in

hospitals under appropriate supervision." .

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Immediately after regulation 8 of the principal regulations, Adds new

regulation to the

there shall be added the following new regulation

principal

regulations.

" Admission to

9. (1) Admission

to

specialist

specialist

medical training shall be contingent upon

medical training.

completion and validation of a basic medical

training programme as referred to in regulation

8(2) in the course of which the trainee has

acquired the relevant knowledge of basic

medicine.

(2) Specialist medical training shall

comprise theoretical and practical training at a

university or medical teaching hospital or,

where

appropriate,

a

medical

care

establishment approved for that purpose by the

competent authorities or bodies. The minimum

duration of specialist medical training courses

referred to in Part Ic of Schedule 2 to the

Health Care Professions Act shall be as stated

in that Part. Training shall be given under the

supervision of the competent authorities or

bodies. It shall include personal participation

of the trainee specialised doctor in the activity

and responsibilities entailed by the services in

question.

(3) Training shall be given on a full-

time

basis

at

specific

recognised

establishments. It shall entail participation in

the full range of medical activities of the

department where the training is given,

including duty on call, in such a way that the

trainee specialist devotes all his professional

activity to his practical and theoretical training

throughout the entire working week and

throughout the year, in accordance with the

procedures laid down by the competent

authorities. These posts shall be the subject of

appropriate remuneration.

(4) In the event that national legislation

provides for partial exemptions from parts of

the specialist medical training courses listed in

Part 1c of the Second Schedule to the Health

Care Professions Act, then such exemptions

shall

(a)

be applied on a case-by-case

basis provided that that part of the

training has been followed already during

another specialist training course listed in

Part 1c of the Second Schedule, for

which the professional has already

obtained the professional qualification in

a Member State; and

(b) shall equate to not more than

half of the minimum duration of the

specialist medical training course in

question.

Any national legislation related to

such partial exemptions shall be notified to the

European Commission and other Member

States by the relevant designated authority.

(5) The issuance of evidence of

specialist medical training shall be contingent

upon possession of evidence of basic medical

training referred to in Part 1a of Schedule 2 to

the Health Care Professions Act." .

Part VI

Amendments to the Designation of Various Entities Regulations

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

(1) This Part amends the Designation of Various Amendments to

Entities Regulations, and it shall be read and construed as one with the

of Various

the Designation of Various Entities Regulations hereinafter in this Entities

Regulations.

Part referred to as "the principal regulations".

(2) The regulations included in this Part implement certain

provisions of Commission Directive 2013/55/EU, and they are made

by virtue of the powers conferred by article 38 of the Various Laws

(Transposition of Directive 2013/55/EU) (Amendment) Act, 2016, on

the Minister for Education and Employment, in consultation with the

Minister for the Economy, Investment and Small Business, in

pursuance of the powers conferred by article 12 of the Services

(Internal Market) Act.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 6 of the principal regulations shall be amended Amends

regulation 6 of

as follows

the principal

regulations.

(a)

the present regulation shall be re-numbered as sub-

regulation (1) thereof; and

(b)

immediately after sub-regulation (1) thereof, as re-

numbered, there shall be added the following new sub-

regulations

"(2) The following information shall be made

available online and through the point of single contact

(a) a list of all regulated professions in

Malta including contact details of the designated

authorities for each regulated profession and

assistance centres;

(b) a list of the professions for which a

European Professional Card in terms of Directive

2005/36/EC is available, the functioning of that

Card, including all related fees to be paid by

professionals, and the designated authorities

responsible for issuing that Card;

(c) a list of all professions for which Malta

applies Article 7(4) of Directive 2005/36/EC under

national laws, regulations and administrative

provisions;

(d) a list of regulated education and training,

and training with a special structure, referred to in

point (c)(ii) of Article 11 of Directive 2005/36/EC;

(e) the requirements and procedures referred

to in Articles 7, 50, 51 and 53 of Directive 2005/

36/EC for the professions regulated in Malta,

including all related fees to be paid by citizens and

documents to be submitted by citizens to

designated authorities;

(f) details on how to appeal, under national

laws, regulations and administrative provisions,

decisions of designated authorities adopted under

Directive 2005/36/EC.

(3) The information referred to in sub-regulation

(2) shall be updated regularly, shall be accessible remotely

and by electronic means by users, and shall be clear and

comprehensive. Any requests for information addressed to

the point of single contact shall be replied to as soon as

possible.".

Part VII

Amendments to the Electrical Installations Regulations

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

(1) This Part amends the Electrical Installations Amendments to

Regulations, and it shall be read and construed as one with the the

Installations

Electrical Installations Regulations hereinafter in this Part referred to Regulations.

as "the principal regulations".

(2) The regulations included in this Part implement certain

provisions of Commission Directive 2013/55/EU, and they are made

by virtue of the powers conferred by article 38 of the Various Laws

(Transposition of Directive 2013/55/EU) (Amendment) Act, 2016, on

the Minister for Education and Employment, in consultation with the

Minister responsible for Energy, in pursuance of the powers conferred

by article 37 of the Regulator for Water and Energy Act.

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

In sub-regulation (2) of regulation 2 of the principal Amends

regulations, immediately after the definition "kW" there shall be regulation

the principal

added the following new definition

regulations.

" "lifelong learning" means all general education,

vocational education and training, non-formal education and

informal learning undertaken throughout life, resulting in an

improvement in knowledge, skills and competences, which may

include professional ethics;".

Malta Government Gazette — Legal Notice 2016 270 · Gazzetta tal-Gvern ta’ Malta Nru. 19,615 – 29.07.2016 — Subsidiary Legislation (Transposition of Directive 2013/55/EU)

Regulation 10 of the principal regulations shall be Amends

regulation 10 of

amended as follows

the principal

regulations.

(a)

in paragraph (b) of sub-regulation (1) thereof, for

the words "two years" there shall be substituted the words "one

year";

(b) in paragraph (d) of sub-regulation (2) thereof, for

the words "two years" there shall be substituted the words "one

year";

(c)

in sub-regulation (3) thereof, for the words "public

health, safety and security" there shall be substituted the words

"public health or safety, and that it cannot be compensated by

the service provider’s professional experience or knowledge,

skills and competences acquired through lifelong learning

formally validated to that end by a relevant body";

(d) for sub-regulation (5) thereof there shall be

substituted the following

"(5) No later than one month after receipt of the

declaration and accompanying documents, referred to in

sub-regulation (2), the Regulator shall inform the applicant

of its decision

(a) not

to

check

his

professional

qualifications; or

(b) having

checked

his

professional

qualifications, to either require the applicant to

take an aptitude test or to allow the provision of

services."; and

(e)

for sub-regulation (6) thereof there shall be

substituted the following

"(6) Where there is a difficulty which would result

in delay in taking a decision under the paragraph (b) of

sub-regulation (5), the Regulator shall notify the applicant

of the reason for the delay within the same deadline. The

difficulty shall be solved within one month of that

notification and the decision finalised within two months

of resolution of the difficulty.".

€4.68

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