for Human Use (Amendment) Regulations, 2012

L.N. 476 of 2012

MEDICINES ACT

(CAP. 458)

Manufacture and Importation of Medicinal Products

for Human Use (Amendment) Regulations, 2012

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister of Health, the Elderly and Community

Care has made the following regulations:-

The title of these regulations is the Manufacture and

Importation of Medicinal Products for Human Use Regulations

(Amendment) Regulations, 2012 and these regulations shall be read

and construed as one with the Manufacture and Importation of

Medicinal Products for Human Use Regulations, hereinafter referred

to as "the principal regulations".

In regulation 2 of the principal regulations for the

definition "active substance (API)" there shall be substituted the

following

" "active substance (API)" means any substance or mixture

of substances intended to be used in the manufacture of a

medicinal product and that, when used in its production,

becomes an active ingredient of that product intended to exert a

pharmacological, immunological or metabolic action with a

view to restoring, correcting or modifying physiological

functions or to make a medical diagnosis;".

Immediately after sub-regulation (5) of regulation 3 of the

principal regulations there shall be added the following new sub-

regulation

"(6) The Authority shall enter the information relating to

the licence referred to in sub-regulation (1) in the European

Union database referred to in Article 111(6) of Directive 2001/

83/EC as amended.".

Immediately after regulation 3 of the principal regulations

there shall be added the following new regulation

" Registering of

3A. (1) Importers and manufacturers

activity with

of active substances who are established in

the Authority.

Malta shall register their activity with the

Licensing Authority.

(2) The registration form shall include,

at least, the following information

(a)

name or corporate name and

permanent address;

(b) the active substances which

are to be imported or manufactured;

(c)

particulars regarding the

premises and the technical equipment

for their activity

Provided that the persons referred to in

sub-regulation (1) shall submit the

registration form to the Licensing Authority at

least sixty days prior to the intended

commencement of their activity.

(3) The Licensing Authority may,

based on a risk assessment, decide to carry

out an inspection. If the Licensing Authority

notifies the applicant within sixty days of the

receipt of the registration form that an

inspection will be carried out, the activity

shall not begin before the Licensing Authority

has notified the applicant that he may

commence the activity. If within sixty days of

the receipt of the registration form the

Licensing Authority has not notified the

applicant that an inspection will be carried

out, the applicant may commence the activity.

(4) The persons referred to in sub-

regulation (1) shall communicate annually to

the Licensing Authority an inventory of the

changes which have taken place as regards the

information provided in the registration form.

Any changes that may have an impact on the

quality or safety of the active substances that

are manufactured or imported shall be

notified immediately.

(5) Persons referred to in sub-

regulation (1) who had commenced their

activity before 2 January 2013 shall submit

the registration form to the competent

authority by 2 March 2013.

(6) Member States shall enter the

information provided in accordance with sub-

regulation (2) in the European Union database

referred to in Article 111(6) of Directive

2001/83/EC, as amended.

(7) This regulation shall be without

prejudice to articles 101 and 102 of the

Medicines Act.".

Regulation 7 of the principal regulations shall be amended

as follows

(a)

subregulation (1) thereof shall be substituted by the

following

"(1) The holder of the licence, apart from his

obligations in article 44 of the Act, shall

(a) comply with the Community principles

and guidelines of good manufacturing practice

and any annexes thereof for medicinal products

and use only active substances which have been

manufactured in accordance with the Community

guidelines on good manufacturing practice for

active substances and distributed in accordance

with good distribution practices for active

substances. To this end, the holder of the

manufacturing

authorisation

shall

verify

compliance by the manufacturer and distributors

of active substances with good manufacturing

practice and good distribution practices by

conducting audits at the manufacturing and

distribution sites of the manufacturer and

distributors of active substances. The holder of

the manufacturing authorisation shall verify such

compliance either by himself or, without

prejudice to his responsibility as provided for in

these regulations and in the Act , through an entity

acting on his behalf under a contract;

(b) ensure that the excipients are suitable

for use in medicinal products by ascertaining what

the appropriate good manufacturing practice is.

This shall be ascertained on the basis of a

formalised risk assessment in accordance with the

applicable guidelines referred to in the fifth

paragraph of Article 47 of Directive 2001/83/EC,

as amended. Such risk assessment shall take into

account requirements under other appropriate

quality systems as well as the source and intended

use of the excipients and previous instances of

quality defects. The holder of the manufacturing

authorisation shall ensure that the appropriate

good manufacturing practice, so ascertained, is

applied. The holder of the manufacturing

authorisation shall document the measures taken

under this paragraph;

(c) inform the competent authority and the

marketing authorisation holder immediately if he

obtains information that medicinal products

which come under the scope of his manufacturing

authorisation are, or are suspected of being,

falsified irrespective of whether those medicinal

products were distributed within the legal supply

chain or by illegal means, including illegal sale by

means of information society services;

(d) verify that the manufacturers, importers

or distributors from whom he obtains active

substances are registered with the competent

authority of the Member State in which they are

established;

(e) verify the authenticity and quality of

the active substances and the excipients."; and

(b) immediately after sub-regulation (2) thereof, there

shall be added the following new sub-regulations

"(3) The safety features referred to in

regulation 3(o) of the Medicinal Products

(Labelling and Packaging) Regulations shall

not be removed or covered, either fully or

partially, unless the following conditions are

fulfilled

(a)

the manufacturing licence

holder verifies, prior to partly or fully

removing or covering those safety

features, that the medicinal product

concerned is authentic and that it has not

been tampered with;

(b) the manufacturing licence

holder complies with regulation 3(o) of

the Medicinal Products (Labelling and

Packaging) Regulations, by replacing

those safety features with safety features

which are equivalent as regards the

possibility to verify the authenticity,

identification and to provide evidence of

tampering of the medicinal product.

Such replacement shall be conducted

without

opening

the

immediate

packaging. Safety features shall be

considered equivalent if they

(i) comply

with

the

requirements as may be adopted by

the European Union Commission

pursuant to Article 54a(2) of

Directive 2001/83/EC as amended;

and

(ii) are equally effective

in enabling the verification of

authenticity and identification of

medicinal

products

and

in

providing evidence of tampering

with medicinal products;

(c)

the replacement of the safety

features is conducted in accordance with

applicable good manufacturing practice

for medicinal products; and

(d) the replacement of the safety

features is subject to supervision by the

Licensing Authority through inspections

or any other means as may be

determined by the same Authority.

(4) Manufacturing licence holders,

including those performing the activities

referred to in sub-regulation (3), shall be

regarded as producers and therefore held

liable for damages in the cases and under the

conditions set forth in the Consumers Affairs

Act.

(5) It shall be the duty of the importer

to ensure that

(a) in the case of medicinal

products and investigational medicinal

products imported from third countries,

these have been manufactured in

accordance with standards which are at

least

equivalent

to the good

manufacturing practice standards laid

down by the Community;

(b) in the case of medicinal

products, such products have been

manufactured by manufacturers duly

authorised for the purpose; and

(c)

in the case of investigational

medicinal products, such products have

been manufactured by a manufacturer

notified to the competent authorities and

accepted by them for that purpose.".

Immediately after sub-regulation (2) of regulation 11 of the Amends

principal regulations, there shall be added the following new sub- regulation

11 of

the principal

regulation

regulations.

"(3) The qualified person shall, in the

case of medicinal products intended to be

placed on the market in the European Union,

ensure that the safety features referred to in

regulation 3(o) of the Medicinal Products

(Labelling and Packaging) Regulations have

been affixed on the packaging.".

Immediately after regulation 12 of the principal Adds new

regulation to the

regulations, there shall be added the following new regulation

principal

regulations.

" Offences and

Any breaches of

penalties.

(a)

regulations 3 and 3A shall be

an offence and shall be liable to

penalties under article 99(1)(a) of the

Act;

(b) regulations 7 and 8 shall be

an offence and shall be liable to

penalties under article 99(1)(b) of the

Act;

(c)

regulations 11 and 12 shall

be an offence and shall be liable to

penalties under article 99(1)(c) of the

Act.".

€0.63