PARALLEL IMPORTATION OF MEDICINAL PRODUCTS REGULATIONS

SUBSIDIARY LEGISLATION 458.40

PARALLEL IMPORTATION OF MEDICINAL

PRODUCTS REGULATIONS

12th October, 2004

LEGAL NOTICE 437 of 2004, as amended by Legal Notice 291 of 2014.

The title of these regulations is the Parallel Importation of

Medicinal Products Regulations.

For the purpose of these regulations -

"the Act" means the Medicines Act;

"the Commission" means the Commission of the European

Union;

"Maltese-market product" means the medicinal product for

which a marketing authorisation has been granted in Malta, with

which the parallel imported medicinal product is compared;

"Member State" me ans a State w hich is a member o f 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) a wholesale dealer’s licence in accordance with the

provisions of the Wholesale Distribution and

Brokering of Medicinal Products and Active

Substances 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 and any other material in accordance

with the provisions of this regulation.

(2) Such application as is mentioned in subregulation (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

parallel imported products that fulfill the following criteria

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

authorisation in Malta when the application for a

parallel import licence is received;

(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 a written declaration stating that the marketing

authorisation holder of the original product marketed

in Malta has been notified about the product being put

on sale in Malta, one month prior to submitting the

application to the Licensing Authority;

(d) submit, in the case of repackaging of a medicinal

product, a sample of the proposed repackaged product

to the marketing authorisation holder of the original

product marketed in Malta;

(e) submit to the Licensing Authority a copy of the

declaration sent to the marketing authorisation holder

referred to in paragraph (c) and, in the case of re-

packaging of a medicinal product, a specimen of the

proposed re-packaged product together with the

application for a parallel import licence;

(f)

ensure that the parallel import licence number

assigned by the Licensing Authority is present on the

outer packaging of the medicinal products.

(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

subregulation (1) shall be submitted to the Licensing Authority

without delay.

The parallel importer shall have in place a system for

handling of pharmacovigilance issues including

(a) a system for identifying and reporting adverse

reactions;

(b) a system for safety recalls; and

(c)

a system for the implementation of risk management

plans (RMP) and direct healthcare professional

communication letters (DHPC).