Regulations, 2013

L.N. 349 of 2013

MEDICINES ACT

(CAP. 458)

Medicines (Marketing Authorisation) (Amendment)

Regulations, 2013

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister for Health, after consultation with the

Licensing Authority, has made the following regulations:-

(1) The title of these regulations is the Medicines Citation, scope

(Marketing Authorisation) (Amendment) Regulations, 2013, and and

commencement.

these regulations shall be read and construed as one with the

Medicines (Marketing Authorisation) Regulations, hereinafter S.L.458.34

referred to as "the principal regulations".

(2) The scope of these regulations is to transpose the

amendments to Directive 2001/83/EC on the community code

relating to medicinal products for human use brought about by

Directive 2012/26/EU, as regards pharmacovigilance.

(3) These regulations shall be deemed to have come into force

on the 28th October, 2013.

For sub-regulation (5) of regulation 18 of the principal Amends

regulations there shall be substituted the following new sub- regulation

the principal

regulation

regulations.

"(5) After a marketing authorisation has been granted,

the holder of the authorisation shall inform the Authority of the

date of actual marketing of the medicinal product for human use

in Malta, taking into account the various presentations

authorised.

If the product ceases to be placed on the Maltese market,

either temporarily or permanently, the marketing authorisation

holder shall notify the Medicines Authority. Such notification

shall, other than in exceptional circumstances, be made no less

than two months before the interruption in the placing on the

market of the product. The marketing authorisation holder shall

inform the Medicines Authority of the reasons for such action in

accordance with regulation 23(7).".

Regulation 23 of the principal regulations shall be

amended as follows

(a)

in the last paragraph of sub-regulation (4) thereof,

for the words from "However, where urgent action" to the words

"shall apply." there shall be substituted the following

"However, where one of the criteria listed in

regulation 57(1)(a)(i) of the Pharmacovigilance

Regulations is met, the procedure laid down in regulation

57 thereof applies."; and

(b) immediately after sub-regulation (6) thereof, there

shall be added the following new sub-regulations

"(7) (a) Where the referral to the Committee

concerns a range of medicinal products or a therapeutic

class, the Agency may limit the procedure to certain

specific parts of the authorisation. In that event, regulation

24 shall apply to those medicinal products only if they

were covered by the authorisation procedures referred to in

regulations 22 and 23.

(b) Where the scope of the procedure initiated

under regulations 22 and 23 concerns a range of medicinal

products or a therapeutic class, medicinal products

authorised in accordance with Regulation (EC) No 726/

2004 which belong to that range or class shall also be

included in the procedure.

(8) Without prejudice to sub-regulation (4), the

Licensing Authority may, where urgent action is necessary

to protect public health at any stage of the procedure,

suspend the marketing authorisation and prohibit the use of

the medicinal product concerned in Malta until a definitive

decision is adopted. It shall inform the Commission, the

Agency and the other Member States, no later than the

following working day, of the reasons for its action.

(9) Where the scope of the procedure initiated in

accordance with sub-regulation (7) includes medicinal

products authorised in accordance with Regulation (EC)

No 726/2004, the Commission may, where urgent action is

necessary to protect public health, at any stage of the

procedure, suspend the marketing authorisations and

prohibit the use of the medicinal products concerned until

a definitive decision is adopted. The Commission shall

inform the Agency and the Licensing Authority no later

than the following working day of the reasons for its

action.".

Immediately after regulation 30 of the principal Adds new

regulation 31 to

regulations there shall be added the following new regulation

the principal

regulations.

" Informing the

(1) The Medicines Authority

shall take all the appropriate measures to

Agency of the

actions taken.

ensure that decisions authorising marketing,

refusing

or

revoking

a

marketing

authorization, cancelling a decision refusing

or revoking a marketing authorization,

prohibiting supply, or withdrawing a product

from the market, together with the reasons on

which such decisions are based, are brought to

the attention of the Agency forthwith.

(2) The marketing authorisation holder

shall be obliged to notify the Medicines

Authority forthwith of any action taken by the

holder to suspend the marketing of a

medicinal product, to withdraw a medicinal

product from the market, to request the

withdrawal of a marketing authorisation or

not to apply for the renewal of a marketing

authorisation, together with the reasons for

such action. The marketing authorisation

holder shall in particular declare if such action

is based on any of the grounds set out in

article 28(1) of the Medicines Act.

(3) The marketing authorisation holder

shall also make the notification pursuant to

sub-regulation (2) in cases where the action is

taken in a third country and where such action

is based on any of the grounds set out in

article 28(1) of the Medicines Act.

(4) The marketing authorisation holder

shall furthermore notify the Agency where the

action referred to in sub-regulation (2) is

based on any of the grounds referred to in

article 28 of the Medicines Act.

(5) The Medicines Authority shall

ensure that appropriate information about

action taken pursuant to sub-regulations (1)

and (2) which may affect the protection of

public health in third countries is forthwith

brought to the attention of the World Health

Organization, with a copy to the Agency.".

€0.36