Medicinal Products (Labelling and Packaging)

L.N. 372 of 2012

MEDICINES ACT

(CAP. 458)

Medicinal Products (Labelling and Packaging)

(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, after consultation with the Licensing Authority, has made the

following regulations:-

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

Products (Labelling and Packaging) (Amendment) Regulations, 2012, and

force.

and these regulations shall be read and construed as one with the

Medicinal Products (Labelling and Packaging) Regulations, S.L. 458.33

hereinafter referred to as "the principal regulations".

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

to Directive 2001/83/EC on the Community code relating to

medicinal products for human use, brought about by Directive 2010/

84/EU, as regards pharmacovigilance and Directive 2011/62/EU, as

regards the prevention of the entry into the legal supply chain of

falsified medicinal products.

(3) Regulations 3 and 4 shall come into force on the 2nd

January, 2013.

In paragraph (n) of regulation 3 of the principal Amends

regulations, for the words "instructions for use." there shall be regulation

the principal

substituted the words "instructions for use;", and immediately regulations.

thereafter there shall be added the following new paragraphs

"(o) for

medicinal

products

other

than

radiopharmaceuticals referred to in paragraph (p), safety

features enabling wholesale distributors and persons authorised

or entitled to supply medicinal products to the public to

(i) verify the authenticity of the medicinal

product, and

(ii) identify individual packs,

as well as a device allowing verification of whether the outer

packaging has been tampered with;

(p)

medicinal products subject to prescription shall bear

the safety features referred to in paragraph (o), unless they have

been listed in accordance with the procedure pursuant to Article

54a of Directive 2001/83/EC as amended.

Medicinal products not subject to prescription shall not

bear the safety features referred to in paragraph (o), unless, by

way of exception, they have been listed in accordance with the

procedure pursuant to Article 54a of Directive 2001/83/EC as

amended, after having been assessed to be at risk of

falsification;

(q) the Licensing Authority may, for the purposes of

reimbursement or pharmacovigilance, extend the scope of

application of the unique identifier referred to in paragraph (o)

to any medicinal product subject to prescription or subject to

reimbursement;

(r)

the Licensing Authority may, for the purposes of

reimbursement, pharmacovigilance and pharmacoepidemiology,

use the information contained in the repositories system as may

be established by the Commission referred to in Article 54a of

Directive 2001/83/EC as amended;

(s)

the Licensing Authority may, for the purposes of

patient safety, extend the scope of application of the anti-

tampering device referred to in paragraph (o) to any medicinal

product.".

Immediately after regulation 5 of the principal regulations,

there shall be added the following new regulation

" Licensing

Notwithstanding the proviso to

regulation 8(2), the Licensing Authority may

Authority may

require use of

require the use of certain forms of labelling of

certain

labelling forms.

the medicinal product making it possible to

ascertain

(a)

the price of the medicinal

product;

(b) the

reimbursement

conditions

of

social

security

organizations;

(c)

the legal status for supply to

the patient, in accordance with Title VI

of Directive 2001/83/EC as amended;

and

(d) authenticity

and

identification in accordance

with

regulation 3(q), (r) and (s).".

4. Sub-regulation (1) of regulation 7 of the principal Amends

regulation 7 of

regulations shall be amended as follows

the principal

regulations.

(a) paragraph (e) thereof shall be substituted by the

following new paragraph

"(e) a description of the adverse reactions which

may occur under normal use of the medicinal product and,

if necessary, the action to be taken in such a case;";

(b) in paragraph (h) thereof, for the words "the package

leaflet was last revised.", there shall be substituted the words

"the package leaflet was last revised;"; and

(c)

immediately after paragraph (h) thereof, there shall

be added the following new paragraphs

"(i) for medicinal products included in the

list referred to in Article 23 of Regulation (EC)

No 726/2004, the following additional statement

shall be included "This medicinal product is

subject to additional monitoring". This statement

shall be preceded by the black symbol referred to

in Article 23 of Regulation (EC) No 726/2004

and followed by an appropriate standardized

explanatory sentence.

For all medicinal products, a standardized text shall

be included, expressly asking patients to communicate any

suspected adverse reaction to his/her doctor, pharmacist,

healthcare professional or directly to the national

spontaneous reporting system referred to in regulations 24

and 25 of the Pharmacovigilance Regulations, 2012, and

specifying the different ways of reporting available

(electronic reporting, postal address and/or others) in

compliance with regulation 25 of the Pharmacovigilance

Regulations, 2012.".

5. Sub-regulation (3) of regulation 10 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

the principal

regulations.

"(3) When the medicinal product is not intended to be

delivered directly to the patient, or where there are severe

problems in respect of the availability of the medicinal product,

the Licensing Authority may, subject to measures they consider

necessary to safeguard human health, grant an exemption to the

obligation that certain particulars should appear on the labelling

and in the package leaflet. They may also grant a full or partial

exemption to the obligation that the labelling and the package

leaflet have to be in the official language or languages of

Malta.".

€0.36