Wholesale Distribution of Medicinal Products Regulations, 2005

L.N. 386 of 2005

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Wholesale Distribution of Medicinal Products Regulations, 2005

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>-

(1) The title of these regulations is the Wholesale Distribution

of Medicinal Products Regulations, 2005.

(2) These regulations shall come into force on the 30 th

October, 2005.

(3) The scope of these regulations is to transpose Directive

2001#83#EEC.

For the purposes of these regulations-

“the Agency” means the European Medicines Agency

established by Regulation (EC) No 726#2004<

“applicant” includes a holder or licensee<

“the Commission” means the Commission in accordance with

Council Decision 1999#468#EC of 28 th June, 1999<

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

European Union and includes, Iceland, Norway and Liechtenstein<

“responsible person” means a person registered as a

pharmacist with the Pharmacy Council and recognised as suitable

by the Medicines Authority since such person possesses adequate

knowledge of the conditions required for the storage and

distribution of medicinal products in order to avoid their

deterioration or damage, has adequate knowledge of the regulations

concerning the distribution of medicinal products, and has

knowledge and understanding of good distribution practice.

(1) (a) Only products in respect of which a marketing

authorisation has been granted by the Licensing Authority, hereinafter

referred to as “the Authority”, or the Agency shall be distributed in

Malta.

(b) In the case of wholesale distribution and storage,

medicinal products shall be covered by a marketing authorisation

granted by the Agency or by the competent authority of a Member

State>

Provided that in the case where medicinal products are stored

but not distributed in Malta, only the licence laid down in regulation

4 hereof, shall be required.

(2) Any distributor, not being the marketing authorisation

holder, who brings into Malta a product from another Member State,

shall notify the marketing authorisation holder and the Authority of

each product he intends to bring into Malta. In the case of products

which have not been granted an authorisation pursuant to Regulation

(EC) No 726#2004, the notification to the Authority shall be without

prejudice to additional procedures provided for in the law at the time>

Provided that where the distributor intends to place the product

on the market in Malta, he shall notify the Authority of each batch he

brings into Malta.

No person shall engage in the wholesale distribution of Wholesale dealer’s

licence.

medicinal products unless he is in possession of a wholesale dealer’s

licence, hereinafter referred to as “licence”, to that effect.

(1) The Licensing Authority, hereinafter referred to as “the Inspection of

Authority”, may inspect any premises and check any person authorised premises.

to engage in the activity of wholesaler in medicinal products.

(2) If the Authority deems that any of the conditions of the

licence issued by it has not been met, it shall suspend or revoke such

licence.

(3) If a licence has been granted in another Member State

and the Authority deems that the licensee is not fulfilling the conditions

set therein, it shall inform the Commission and the Member State

concerned.

(1) The Authority shall process an application for a wholesale Processing of

applications.

dealer’s licence within ninety days of receipt of the application. This

period shall be suspended in those cases where the applicant is requested

to furnish additional data.

(2) The application shall, apart from the particulars listed

under article 55(1) of the Act, also include the pharmaceutical forms of

the products to be distributed, in particular any sterile products and

products requiring storage below 8 degrees Centigrade, and details of

narcotic or psychotropic substances, blood, immunological medicinal

products, or radiopharmaceuticals.

(1) A wholesale distribution licence shall only be granted if

the Authority is satisfied that the applicant has at least -

(a) suitable and adequate premises, installations and

equipment, so as to ensure proper conservation and distribution of

the medicinal products<

(b) adequate staff, and in particular, a responsible person.

(2) A licence shall not be granted or renewed unless the

applicant>

(a) makes the premises, installations and equipment

accessible at all times for inspection<

(b) obtains the supplies of medicinal products from persons

who are themselves in possession of a distribution licence, or who

are exempt from obtaining such authorisation under the terms of

regulation 3(4) of the Manufacturing and Importation of Medicinal

Products for Human Use Regulations, 2005<

(c) supplies medicinal products to persons who are

themselves in possession of a wholesale distribution licence or

who are otherwise authorised or entitled to supply medicinal

products to the public<

(d) has an emergency plan which ensures effective

implementation of any recall of medicinal products from the market

as ordered by the Authority or carried out in co-operation with the

manufacturer or marketing authorization holder for the medicinal

product concerned<

(e) keeps records available for inspection by the Authority,

for a period of five years of any transaction in medicinal products

received or dispatched, containing the following information>

(i) date<

(ii) name and pharmaceutical form of the medicinal

product<

(iii) quantity received or supplied<

(iv) name and address of the supplier or consignee, as

appropriate<

(f) complies with the principles and guidelines of good

distribution practice for medicinal products as published by the

Commission.

(1) It shall be the duty of the wholesale dealer, when Duty of wholesale

dealer.

supplying medicinal products to a person authorised or entitled to supply

them to the public, to enclose a document thereby making it possible to

ascertain the date, name and pharmaceutical form of the medicinal

product, quantity supplied and the name and address of the supplier or

consignee.

(2) In addition, the wholesale dealer shall, in respect of each

product he is distributing in Malta, furnish to the Authority an

authenticated copy of the marketing authorization together with a letter

of access issued by the marketing authorization holder granting the

wholesale dealer the use of such marketing authorisation>

Provided that a wholesale dealer may only engage in the

wholesale distribution of medicinal products in Malta in respect of which

no such authenticated copy of a valid marketing authorization and letter

of access has been forwarded to the Authority, if he is in possession of

a parallel import licence issued in terms of the law.

(3) Every wholesale dealer shall, within the limits of his

responsibilities, ensure that an appropriate and continuous supply of

medicinal products is furnished to pharmacies and persons authorized

to supply medicinal products in order to satisfy the needs of patients.

Duty of responsible

It shall be the duty of the responsible person to>

person.

(a)

ensure that the licence conditions are adhered to<

(b) ensure that the conditions for storage of medicinal

products are in accordance with the requirements of the marketing

authorisation and labelling<

(c)

monitor all areas used for storage and distribution<

(d) maintain records as required by these regulations<

(e) ensure that a quality system is maintained by the licensee

in accordance with good distribution practice.

The provisions of these regulations shall also apply to

homeopathic medicinal products.

The Importation and Wholesale Distribution of Medicinal

Products Regulations, 2004 are hereby being repealed.