and Active Substances Regulations, 2012

L.N. 478 of 2012

MEDICINES ACT

(CAP. 458)

Wholesale Distribution and Brokering of Medicinal Products

and Active Substances Regulations, 2012

IN exercise of the powers conferred by article 106 of the

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

Care has made the following regulations:-

(1) The title of these regulations is the Wholesale Citation and

Distribution and Brokering of Medicinal Products and Active scope.

Substances Regulations, 2012.

(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.

For the purposes of these regulations -

Interpretation.

"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 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 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 Registering of

established in Malta shall register their activity with the Licensing activity

Authority.

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 Cap. 458.

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

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

"the Authority", may inspect any premises and check any person premises.

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;

(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 such a case the

wholesale distributor should 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;

(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;

(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

Duty of

responsible

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

homeopathic medicinal products.

products.

Without prejudice to any of these regulations, the Falsified

Licensing Authority shall take the necessary measures in order to medicinal

products.

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(1a) 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.

The Wholesale Distribution of Medicinal Products

Regulations, 2005 are hereby revoked.

2005.

2005. €0.72