obligations) Regulations, 2022

L.N. 234 of 2022

MEDICINES ACT

(CAP. 458)

Medicinal Products for Human Use (Derogations from certain

obligations) Regulations, 2022

IN EXERCISE of the powers conferred by article 106 of the

Medicines Act, the Minister responsible for public health, after

consultation with the Licensing Authority, has made the following

regulations:-

The title of these regulations is the Medicinal Products for Citation.

Human Use (Derogations from certain obligations) Regulations, 2022.

These regulations shall be deemed to have come into force Commencement.

on the 1st January 2022.

The scope of these regulations is to transpose Directive (EU) Scope.

2022/642 of the European Parliament and of the Council of 12 April

2022 amending Directives 2001/20/EC and 2001/83/EC as regards

derogations from certain obligations concerning certain medicinal

products for human use made available in the United Kingdom in

respect of Northern Ireland and in Cyprus, Ireland and Malta.

The derogations stipulated in these regulations are for the Derogations.

purpose of preventing shortages of medicinal products and ultimately

to ensure a high level of public health protection. By virtue of these

derogations medicinal products from or transiting through parts of the

United Kingdom, may temporarily be allowed.

Part I

Amendments to the Medicines (Marketing Authorisation)

Regulations

This Part amends the Medicines (Marketing Authorisation) Amendments to

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

(Marketing

(Marketing Authorisation) Regulations, hereinafter in this Part referred Authorisation)

Regulations.

to as the "the principal regulations".

Immediately after regulation 2 of the principal regulations Adds new

regulation 2A to

the principal

regulations.

there shall be added the following new regulation

2A. (1) The Licensing Authority shall establish,

notify to the Commission and publish on its website a list of

products to be

medicinal products to which it has applied or intends to

apply the derogations as set out in Directive (EU) 2022/642

of the European Parliament and of the Council of 12 April

2022;

(2) The Licensing Authority shall ensure that the list

referred to in sub-regulation (1) is updated and managed in

an independent manner, at least on a six-monthly basis.".

Immediately after regulation 4 of the principal regulations

there shall be added the following new regulation

4A. (1) By way of derogation from regulation

4(2), until the 31st December 2024, in the absence of a

marketing authorisation or of a pending application for a

marketing authorisation, the Licensing Authority may

authorise for justified public health reasons the placing on

the market of a medicinal product authorised in parts of the

United Kingdom other than Northern Ireland

Provided that the Licensing Authority may also

maintain in force or, until the 31st December 2024, extend

marketing authorisations that were granted pursuant to this

sub-regulation before the 20th April 2022 which authorise

the placing on the market of a medicinal product authorised

in parts of the United Kingdom other than Northern Ireland

Provided further that authorisations that are

granted, extended or maintained in force pursuant to the

provisions of this sub-regulation shall not be valid after the

31st December 2026.

(2) By way of derogation from regulation 5(1)(b),

the Licensing Authority may grant marketing authorisations

as referred to in regulation 4(2), to marketing authorisation

holders established in parts of the United Kingdom other

than Northern Ireland.

(3) Where the Licensing Authority grants or

extends a marketing authorisation as referred to in sub-

regulation (1), it shall ensure compliance with the

requirements of this regulation.

(4) Before granting a marketing authorisation

pursuant to sub-regulation (1), the Licensing Authority

(a) shall notify the marketing authorisation

holder in parts of the United Kingdom other than

Northern Ireland of the proposal to grant a marketing

authorisation or to extend a marketing authorisation

under this regulation in respect of the medicinal

product concerned;

(b) may request the competent authority in the

United Kingdom to submit the relevant information

regarding the marketing authorisation of the

medicinal product concerned.".

In regulation 5(1)(b) of the principal regulations the words Amends

"established in the Community;" shall be substituted by the words regulation

"established in the Community:" and immediately after there shall be regulations.

added the following new provisos

"Provided that by way of derogation from the above,

marketing authorisations may be granted until the 31st December 2024,

by the Licensing Authority in accordance with the mutual recognition

or the decentralised procedure laid down under regulation 22 to

marketing authorisation holders established in parts of the United

Kingdom other than Northern Ireland

Provided further that until the 31st December 2024 the

Licensing Authority may extend marketing authorisations already

granted prior to the 20th April 2022 to marketing authorisation holders

established in parts of the United Kingdom other than Northern Ireland

Provided further that marketing authorisations granted or

extended by the Licensing Authority in accordance with the preceding

two provisos shall cease to be valid at the latest on the 31st December

2026.".

Immediately after regulation 5 of the principal regulations Adds new

there shall be added the following new regulation

5A. The derogations set out in regulations 4A and

" Obligations of

the authorisation

5(1) (b), regulations 4 and 22 of the Pharmacovigilance

holder.

Regulations, and regulations 11A, 11B, 11C and 11D of the

Manufacture and Importation of Medicinal Products for

Human Use Regulations shall not affect the obligations of

the marketing authorisation holder to ensure the quality,

safety and efficacy of the medicinal product placed on the

market as laid down in these regulations.".

Part II

Amendments to the Pharmacovigilance Regulations

This Part amends the Pharmacovigilance Regulations and it

shall be read and construed as one with the Pharmacovigilance

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

regulations".

In the proviso to regulation 6(4) of the principal regulations

the words "and the Agency." shall be substituted by the words "and the

Agency:" and immediately thereafter there shall be added the following

new proviso

"Provided further that by way of derogation from the

preceding proviso, where the marketing authorisation is granted

by the competent authority of the United Kingdom in respect of

Northern Ireland, the qualified person referred to in paragraph

(a) of this sub-regulation may reside and operate in parts of the

United Kingdom other than Northern Ireland. This proviso shall

not apply where the marketing authorisation holder already has

at its disposal a qualified person who resides and operates in the

European Union on 20 April 2022.".

Part III

Amendments to the Manufacture and Importation of Medicinal

Products for Human Use Regulations

This Part amends the Manufacture and Importation of

Medicinal Products for Human Use Regulations and it shall be read and

construed as one with the Manufacture and Importation of Medicinal

Products for Human Use Regulations, hereinafter in this Part referred to

as the "the principal regulations".

Regulation 11 of the principal regulations shall be amended

as follows

(a) in the Maltese version only, in paragraph (a) of sub-

regulation (1) thereof, the words "konsenja ta’ prodotti

mediċinali manifatturati f’Malta tkun ġiet manifatturata u

verifikata" shall be substituted by the words "lott ta’ prodotti

mediċinali manifatturati f’ Malta jkun ġie manifatturat u

verifikat";

(b) in the Maltese version only, in paragraph (b) of sub-

regulation (1) thereof, the words "konsenja tal-produzzjoni

għandha tkun għaddiet" shall be substituted by the words "lott

tal-produzzjoni għandu jkun għadda";

(c) in the Maltese version only, in the proviso to

paragraph (b) of sub-regulation (1) thereof, the word "konsenji"

shall be substituted by the word "lottijiet".

Immediately after regulation 11 of the principal regulations Adds new

there shall be added the following new regulations

11A. With regard to quality control testing, carried

out in parts of the United Kingdom other than Northern

Ireland, regarding medicinal products included in the list

referred to in regulation 5A of the Medicines (Marketing

Authorisation) Regulations other than those authorised by

the Commission, until the 31st December 2022, the

Licensing Authority, may consider there is a justifiable case

within the meaning of regulation 11(1)(b), without carrying

out a case-by-case assessment provided that

(a) each batch of the medicinal products

concerned is released by a qualified person on a site

in the Union or in Northern Ireland or by a qualified

person on a site in parts of the United Kingdom

other than Northern Ireland applying quality

standards that are equivalent to those laid down in

regulation 11;

(b) the establishment designated by the third

party conducting the quality control testing is

supervised by the competent authority of the United

Kingdom, including by performing on-the-spot

checks;

(c) where the batch release is carried out by a

qualified person who resides and operates in parts of

the United Kingdom other than Northern Ireland, the

manufacturing authorisation holder declares that it

does not have at its disposal a qualified person who

resides and operates in the Union on the 20th April

2022.

11B. By way of derogation from sub-regulations

requirement of 1(a) and (b) of regulation 3, until the 31st December 2024,

the Licensing Authority shall allow medicinal products to

be imported from parts of the United Kingdom other than

Northern Ireland by holders of a wholesale distribution

authorisation as referred to in regulation 4 of the

Wholesale Distribution and Brokering of Medicinal

Products and Active Substances Regulations, that are not

in possession of a relevant manufacturing authorisation

provided that all of the following conditions are fulfilled

(a) the medicinal products have undergone

quality control testing, either in the Union, as

provided for in regulation 12 or in parts of the

United Kingdom other than Northern Ireland in

compliance with regulation 11(1)(b);

(b) the medicinal products have been subject

to batch release by a qualified person in the Union in

accordance with regulation 11(1) or, for medicinal

products authorised by the Licensing Authority and

the United Kingdom in respect of Northern Ireland, in

parts of the United Kingdom other than Northern

Ireland applying quality standards that are equivalent

to those laid down in regulation 11(1);

(c) the marketing authorisation for the

medicinal product concerned has been granted in

accordance with Union law, by the competent

authority of a Member State or by the Commission or,

as regards medicinal products placed on the market in

Northern Ireland, by the competent authority of the

United Kingdom in respect of Northern Ireland;

(d) medicinal products are only made

available to patients or end-consumers in Malta;

(e) the medicinal products bear the safety

features referred to in regulation 3(o) of the Medicinal

Products (Labelling and Packaging) Regulations.

11C. For batches of medicinal products exported to

parts of the United Kingdom other than Northern Ireland

from a Member State and subsequently imported into

Malta until the 31st December 2024 the controls upon

importation referred to in the sub-regulations (1) and (2)

of regulation 11, shall not be required, provided that those

batches have undergone such controls in a Member State

prior to being exported to parts of the United Kingdom

other than Northern Ireland and that they are accompanied

by the control reports referred to in the said regulation.

11D. Where the manufacturing authorisation is

granted by the competent authority of the United Kingdom

in respect of Northern Ireland, the qualified person referred

to regulation 11(1) may reside and operate in parts of the

United Kingdom other than Northern Ireland, unless the

manufacturing authorisation holder already has at its

disposal a qualified person who resides and operates in the

Union on 20 April 2022.".

In the Maltese version only, in regulation 12(1) the words Amends

"konsenja li tkun ġiet prodotta tkun tissodisfa" shall be substituted by regulation

the words "lott li jkun ġie prodott ikun jissodisfa".

Part IV

Amendments to the Wholesale Distribution and Brokering of

Medicinal Products and Active Substances Regulations

This Part amends the Wholesale Distribution and Brokering Amendments to the

of Medicinal Products and Active Substances Regulations and it shall Distribution and

be read and construed as one with the Wholesale Distribution and Medicinal Products

Brokering of Medicinal Products and Active Substances Regulations, Substances

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

In the Maltese version only, in the proviso to regulation 3(2) Amends

of the principal regulations the word "kunsinna" shall be substituted by regulation

the word "lott".

Regulation 8(2) of the principal regulations shall be amended Amends

as follows

(a) in the proviso to paragraph (b) thereof, the words

"end up on any Member State market;" shall be substituted by

the words "end up on any Member State market:" and

immediately after there shall be added the following new

proviso

"Provided further that the requirements of the

above proviso shall not apply to the import of a medicinal

product meeting the conditions laid down in regulation 11B

of the Manufacture and Importation of Medicinal Products

for Human Use Regulations;".

(b) in the Maltese version only, in sub-paragraph (v) of

paragraph (e) thereof, the word "kunsina" shall be substituted by

the word "lott".

In the Maltese version only, in regulation 9(1) of the

principal regulations the word "kunsinna" shall be substituted by the

word "lott".

Part V

Amendments to the Good Clinical Practice and Requirements for

Manufacturing or Import Authorisation of Investigational

Medicinal Products (Human Use) Regulations

This Part amends the Good Clinical Practice and

Requirements for Manufacturing or Import Authorisation of

Investigational Medicinal Products (Human Use) Regulations and it

shall be read and construed as one with the Good Clinical Practice and

Requirements for Manufacturing or Import Authorisation of

Investigational Medicinal Products (Human Use) Regulations,

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

In sub-regulation (1) of regulation 7 of the principal

regulations the words "dividing up, packaging or presentation." shall be

substituted by the words "dividing up, packaging or presentation:" and

immediately after there shall be added the following new proviso

"Provided that by way of derogation from sub-

regulation (1), the Licensing Authority shall allow

investigational medicinal products to be imported from parts of

the United Kingdom other than Northern Ireland without such

an authorisation provided that all of the following conditions are

fulfilled

(a) the imported investigational medicinal

products have undergone certification of batch release

either in the Union, as provided for in paragraph 3, point

(a) of Article 13 (1) of Directive 2001/20/EC, or in parts of

the United Kingdom other than Northern Ireland in

compliance with the requirements set out in paragraph 3,

point (b) of the same Directive;

(b) the imported investigational medicinal

products are only made available in Malta.".

€0.72