WHOLESALE DISTRIBUTION AND BROKERING OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES REGULATIONS

SUBSIDIARY LEGISLATION 458.37

WHOLESALE DISTRIBUTION AND BROKERING

OF MEDICINAL PRODUCTS AND ACTIVE

SUBSTANCES REGULATIONS

24th December, 2012

LEGAL NOTICE 478 of 2012, as amended by Legal Notices 350 of 2013

and 234 of 2022.

(1) The title of these regulations is the Wholesale

Distribution and Brokering of Medicinal Products and Active

Substances Regulations.

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

2001/83/EC of the European Parliament and of the Council of 6

November 2001 on the Community code relating to medicinal

products for human use as amended by Directive 2011/62/EU of the

European Parliament and of the Council of 8 June 2011 amending

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

products, and Article 85a of Directive 2001/83/EC, as the said Article

has been amended by Directive 2012/26/EU of the European

Parliament and of the Council of 25 October 2012 amending Directive

2001/83/EC as regards pharmacovigilance.

For the purposes of these regulations -

"the Agency" means the European Medicines Agency

established by Regulation (EC) No. 726/2004 of the European

Parliament and of the Council of 31 March 2004 laying down

Community procedures for the authorisation and supervision of

medicinal products for human and veterinary use and establishing a

European Medicines Agency;

"applicant" includes a holder or licensee;

"the Commission" means the Commission in accordance with Council

Decision 1999/468/EC of the 28th 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

M e d i c i n es A u t h o r i t y s i n c e s u c h p e r s o n p o s s e s s e s a d e q u a t e

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

concern ing the distribu tion of med icinal produ ct s, an d has

knowledge and understanding of good distribution practice.

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

a u t h o r i s a t i o n h a s be e n g r a n t e d b y t h e L i c e n s in g

Authority, hereinafter referred to as "the Authority", or

the Agency shall be distributed or brokered in Malta.

(b) In the case of brokering, 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 and in the case of wholesale distribution

of medicinal products to third countries, only the licence laid down in

regulation 4 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 and to fees payable to the

Authority for examining the notification

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.

(3) In the case of medicinal products which have been granted

an authorisation pursuant to Regulation (EC) No. 726/2004, the

distributor shall submit the notification in accordance with sub-

regulation (2) to the marketing authorisation holder and the

Agency. A fee shall be payable to the Agency for checking that the

conditions laid down in European Union legislation on medicinal

products and in the marketing authorisations are observed.

(4) Persons brokering medicinal products established in Malta

shall have a permanent address and contact details, so as to ensure

accurate identification, location, communication and supervision of

their activities by the Licensing Authority.

No person shall engage in the wholesale distribution of

medicinal products unless he is in possession of a wholesale

dealer’s licence, hereinafter referred to as "the licence", to that

effect.

(1) Distributors of active substances who are established in

Malta shall register their activity with the Licensing Authority.

(2) The registration form shall include, at least, the following

information

(a) name or corporate name and permanent address;

(b) the active substances which are to be distributed;

(c) particulars regarding the premises and the technical

equipment for their activity.

The persons referred to in sub-regulation (1) shall submit the

registration form to the Licensing Authority at least sixty days

prior to the intended commencement of their activity.

(3) The Licensing Authority may, based on a risk assessment,

decide to carry out an inspection. If the Licensing Authority

notifies the applicant within sixty days of the receipt of the

registration form that an inspection will be carried out, the activity

shall not begin before the Licensing Authority has notified the

applicant that he may commence the activity. If within sixty days of

the receipt of the registration form the Licensing Authority has not

notified the applicant that an inspection will be carried out, the

applicant may commence the activity.

(4) The persons referred to in sub-regulation (1) shall

communicate annually to the Licensing Authority an inventory of

the changes which have taken place as regards the information

provided in the registration form. Any changes that may have an

impact on the quality or safety of the active substances that are

distributed shall be notified immediately.

(5) Persons referred to in sub-regulation (1) who had

commenced their activity before 2 January 2013 shall submit the

registration form to the competent authority by 2 March 2013.

(6) Member States shall enter the information provided in

accordance with sub-regulation (2) in the European Union database

referred to in Article 111(6) of Directive 2001/83/EC as amended.

(7) This regulation shall be without prejudice to articles 101

and 102 of the Medicines Act, hereinafter referred to as "the Act".

(1) The Licensing Authority, hereinafter referred to as "the

Aut hority ", may insp ect any premises and check any p erson

authorised to engage in the activity of wholesaler in medicinal

products and of active substances, including active substances that

are intended for export.

(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

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 8º 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;

WHOLESALE DISTRIBUTION AND BROKERING OF

MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES

(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

Manufacture and Importation of Medicinal Products

for Human Use Regulations, and verifies that the

medicinal products received are not falsified by

checking the safety features on the outer packaging, in

accordance with the requirements as may be adopted

by the Commission

Provided that the requirements of this paragraph shall not

apply where a medicinal product is directly received from

a third country but not imported, that is to say, not to be

placed on any Member State market. However, in that

case wholesale distributors shall ensure that the

medicinal products are obtained only from persons who

are authorised or entitled to supply medicinal products in

accordance with the applicable legal and administrative

provisions of the third country concerned. The wholesale

distributor should also exercise all necessary caution and

precautions in order to ensure that these medicinal

products not intended to be imported, remain in

quarantine and do not in any way end up on any Member

State market

Provided further that the requirements of the above proviso

shall not apply to the import of a medicinal product

meeting the conditions laid down in regulation 11B of the

Manufacture and Importation of Medicinal Products for

Human Use Regulations;

(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

Provided that in the case of distribution of medicinal

products to third countries this shall not apply. However,

when wholesale distributors supply medicinal products to

persons in third countries, they shall ensure that such

supplies are only made to persons who are authorised or

entitled to receive medicinal products for wholesale

distribution or supply to the public in accordance with the

applicable legal and administrative provisions of the third

country concerned;

(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, either in the form of purchase/sales

invoices, or on computer, or in any other form,

available for inspection by the Authority, for a period of

five years of any transaction in medicinal products

received, dispatched or brokered, containing at least

the following information

(i) date;

(ii) name and pharmaceutical form of the medicinal

product;

(iii) quantity received, supplied or brokered;

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

appropriate;

(v) batch number of the medicinal product;

(f)

complies with the principles and guidelines of good

distribution practice for medicinal products as

published by the Commission;

(g) maintains a quality system setting out responsibilities,

processes and risk management measures in relation to

their activities;

(h) immediately informs the Authority and, where

applicable, the marketing authorisation holder, of

medicinal products he receives or are offered which he

identifies as falsified or suspect to be falsified.

(3) For the purposes of sub-regulation (2)(e), where the

medicinal product is obtained from another wholesale distributor,

the wholesale distribution authorisation holder must verify

compliance with the principles and guidelines of good distribution

practices by the supplying wholesale distributor. This includes

verifying whether the supplying wholesale distributor holds a

wholesale distribution authorisation.

Where the medicinal product is obtained from the

manufacturer or importer, wholesale distribution authorisation

holders shall verify that the manufacturer or importer holds a

manufacturing authorisation. Where the medicinal product is

obtained through brokering, the wholesale distribution

authorisation holder shall verify that the broker involved fulfils the

requirements set out in these regulations and in the Act.

(4) The requirements set out in paragraphs (a) and (d) to (h) of

sub-regulation (2) shall apply mutatis mutandis to the brokering of

medicinal products.

(5) The Authority shall enter the information relating to the

licence referred to in sub-regulation (1) in the European Union

database as may be established by the Commission. At the request

of the Commission or any Member State, the Authority shall

provide all appropriate information concerning the individual

licences which were granted under sub-regulation (1).

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

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, batch number of the medicinal products

and the name and address of the supplier or consignee

Provided that the requirements of this sub-regulation shall

also apply to the supply of medicinal products to persons in third

countries authorised or entitled to supply medicinal products to the

public.

(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.

(4) It shall be the duty of wholesale distributors of active

substances, including active substances that are intended for

export, to comply with the current European Union good

distribution practice for active substances.

It shall be the duty of the responsible person to

(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.

Without prejudice to any of these regulations, the

Licensing Authority shall take the necessary measures in order to

prevent medicinal products that are introduced into the European

Union, but are not intended to be placed on the market of the

European Union, from entering into circulation if there are

sufficient grounds to suspect that those products are falsified.

These measures shall include the application of these regulations to

warehouses situated in free trade zones and customs bonded

warehouses used to store medicinal products.

Any breaches of

(a) regulations 3(1) and 4 shall be an offence and shall be

liable to penalties under article 99(1)(a) of the Act;

(b) regulation 5 shall be an offence and shall be liable to

penalties as prescribed under article 99(1)(b) of the

Act;

(c) regulations 8, 9 and 10 shall be an offence and shall be

liable to penalties as prescribed under article 99(1)(d)

of the Act.