Parallel Importation of Medicinal Products Regulations, 2004

L.N. 437 of 2004

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Parallel Importation of Medicinal Products Regulations, 2004

IN exercise of the powers conferred by article 106 of the

Medicines Act, 2003, the Minister of Health, the Elderly and

Community Care has made the following regulations:-

The title of these regulations is the Parallel Importation of Title.

Medicinal Products Regulations, 2004.

Interpretation.

For the purpose of these regulations-

“the Act” means the Medicines Act, 2003

“the Commission” means the Commission of the European

Union;

“Maltese-market product” means the medicinal product for

which a marketing authorisation has been granted with which

the parallel imported medicinal product is compared;

“Member State” means a State which is a member of the

European Union;

“parallel distribution” means the importation from a

Member State or a country within the European Economic Area

of a centrally authorised medicinal product, by an importer who

is someone other than the importer authorised and appointed

by the marketing authorisation holder of the product on the

Maltese market;

“parallel importation” means the importation from a

Member State or a country within the European Economic Area

of a medicinal product which is already authorised on the

Maltese market, by an importer who is someone other than the

importer authorised and appointed by the marketing

authorisation holder of the product on the Maltese market;

“parallel importer” means a person engaged in the

activities of parallel importation;

“parallel imported product” means a product authorised in

a Member State or a country within the European Economic

Area imported by parallel importation;

“repackaging” includes the removal of blister packs from

the original packaging and their insertion into new external

packaging or addition of new user instructions or information

or the fixing of self-stick labels;

“source country” means the Member State country from

which the parallel imported product is imported.

(1) No person shall engage in the parallel importation

of medicinal product unless he is in possession of a parallel import

licence in respect of each medicinal product, hereinafter referred to

as the licence.

(2) No person shall engage in the parallel importation of

medicinal products unless such a person is in possession of

(a) wholesale dealer’s licence in accordance with the

provisions of the Importation and Wholesale Distribution of

Medicinal Products Regulations, and

(b)

parallel import licence issued by the Authority.

(3) When the holder of the manufacturing licence for

repackaging of a parallel imported product is also the holder of the

parallel import licence in respect of the product, he shall have the

right to distribute by wholesale the repackaged parallel imported

product in respect of which the manufacturing licence has been

issued.

(1) Any application for the granting of a parallel import

licence shall be made to the Licensing Authority and shall contain

such information, documents any other material in accordance with

the provisions of this regulation.

(2) Such application as is mentioned in sub-regulation

(1) shall indicate the following

(a) name, address and contact person of the proposed

parallel import licence holder;

(b) name and address of the applicant, if different from

that of the licence holder;

(c) parallel import licence holder’s trading style on labels

and leaflets;

(d) name, pharmaceutical form, any active ingredient,

strength, pack size details, marketing authorisation holder,

marketing authorisation number of the medicinal product for

which a parallel import licence is being applied for;

(e) name, pharmaceutical form, strength, name and

address of the marketing authorisation holder and marketing

authorisation number of the Maltese-market product;

(f)

copy of the wholesale dealer’s licence and, if the

parallel imported product is to be repackaged, of the

manufacturer’s licence; provided that if the holder of the

manufacturer’s licence is responsible for both repackaging and

distribution of the parallel imported product, then only a copy

of the manufacturer’s licence shall be required; and

(g) basis on which the applicant makes a presumption of

essential similarity between the local and imported product.

(3) The Authority shall process an application for a

parallel import license within forty-five working days of validation

of the application. Such period shall be suspended in those cases

where the applicant is requested to furnish additional data.

(1) A parallel import licence shall only be granted for Granting for a

licence.

parallel imported products that fulfill the following criteria

(a) Maltese-market product shall have a valid marketing

authorisation in Malta;

(b) parallel imported product shall be imported from a

Member State or a country of the European Economic Area

and it must have a valid marketing authorisation in that country;

(c)

parallel imported product shall have the same

pharmaceutical form and be identical to, or have no significant

therapeutic difference from, the Maltese-market product.

(2) A parallel import licence shall cease to be valid if the

marketing authorisation is withdrawn for reasons directly related to

the protection of public health.

A parallel import licence is granted for a period of five

years. An application for the renewal of the parallel import licence

shall be submitted to the Licensing Authority no later than three

months before expiry of the previous licence.

It shall be the duty of a parallel importer to

(a) ensure that there is a clear audit trail from the

authorised distributor or manufacturer in the source country;

(b) submit to the Licensing Authority a declaration that

the supplier is going to keep him informed of any

Pharmacovigilance issues;

(c) provide, in the case of repackaging of a medicinal

product, a written declaration stating that the marketing

authorisation holder of the original product marketed in Malta

has been notified about the repackaged product being put on

sale in Malta, one month prior to submitting the application to

the Medicines Authority. A copy of the letter sent to the

marketing authorisation holder shall also be submitted together

with the application for a parallel import licence;

(d) ensure, in the case of repackaged products, that the

parallel import licence number assigned by the Licensing

Authority is present on the outer packaging of the medicinal

products. In the case where the medicinal product with the

parallel import licence is identical to the Maltese market

product, the same requirements for numbering apply as for the

Maltese market product.

(1) A parallel importer shall at all times keep records of

the origin, imported quantities, and batch numbers of the parallel

imported medicinal products.

(2) Upon request, such information as is referred to in

sub-regulation (1) hereof shall be submitted to the Licensing

Authority without delay.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press