Regulations, 2008 (unzjonidwarir-riklamar)

L.N. 60 of 2008

MEDICINES ACT

(CAP. 458)

Medicines Products (Injunction to Advertising)

Regulations, 2008

IN exercise of the powers conferred by articles 31 and 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 Medicines Products Citation

commencement.

(Injunction to Advertising) Regulations, 2008

(2) These regulations shall come into force on last of

February, 2008.

In these regulations, unless the context otherwise requires>

Interpretation.

“the Act” means the Medicines Act<

“the Authority” means the Medicines Authority established

under article 4 of the Act<

“the Commission” means the Commission of the European

Community<

“Court of Appeal” means the Court of Appeal sitting in its

inferior jurisdiction as constituted in terms of sub-article (6) of

article 41 of the Code of Organization and Civil Procedure<

“the Directive” means the provisions of Directive 98#27#EC

of the European Parliament and of the Council of 19th May, 1998

on injunctions for the protection of consumersí interests<

“EEA State” means any State which is a contracting party to

the agreement on the European Economic Area signed at Oporto

on the 2nd May, 1992 as amended by the Protocol signed at Brussels

on 17th March, 1993 and as amended from time to time<

“European Community” means the organisation established

by the Treaty of Rome in 1957 and amended institutionally and

otherwise in 1986 by the Single European Act, in 1993 by the

Treaty on European Union, in 1997 by the Treaty of Amsterdam

and in 2001 by the Treaty of Nice and as amended by accession

agreements and as may be further amended from time to time<

“list of qualified entities” means the list compiled and updated

by the Commission and published in the Official Journal of the

European Communities listing the qualified entities in Member

States and EEA States in accordance with Article 4 of the Directive<

“medicinal products” means medicinals for human use<

“Member State” means a member of the European

Community<

“the Minister” means the minister responsible for health<

“qualified entity” means any body or organization which,

being properly constituted according to the law of a Member State,

has a legitimate interest in ensuring that the provisions referred to

in article 3 of this Order are complied with and, without prejudice

to the generality of the foregoing, includes>-

(a) a registered consumer association within the

meaning of Part IV of the Consumer Affairs Act<

(b) one or more independent public bodies, having a

legitimate interest in ensuring the protection of the collective

interests of consumers of medicinal products advertising in

other Member States or EEA States in which such bodies

exist<

(c) voluntary organisations in other Member States or

EEA States whose purpose is to protect the interests referred

to in paragraph (a) of this definition in accordance with the

criteria laid down by their national law<

(d) organisations recognised by the Authority as

collectively representing medicinal products manufacturers,

suppliers and distributors< or

(e) any qualified entity from a Member State or EEA

State included in the list of qualified entities<

“the 2005 Regulations” means the “Medicinal Products

(Advertising) Regulations, 2005.

(2) Words and expressions used in these regulations which

are also used in the Act or in the 2005 Regulations shall have the same

meanings as in the Act or in the said regulations.

The object of these regulations is to implement the provisions Object.

of the Directive, as applicable to the advertising of medicinal products

contained in Directive 92#28#EEC as transposed by the 2005 Regulations,

and shall be interpreted and applied accordingly.

These regulations apply to any advertising of medicinal Scope.

products in or from Malta as regulated by Directive 92#28#EEC.

(1) Where a qualified entity wishes to seek a compliance Application for

compliance orders

order, it shall submit its written application to the Authority. In its by qualified entities

application, it shall satisfy the Authority that it has tried to achieve the

cessation of the infringement in consultation with either the defendant

or both the defendant and another qualified entity of the Member State

or EEA State in which the injunction is sought. The Authority shall

only entertain a written application if the qualified entity shows to its

satisfaction that the cessation of the infringement was not achieved

within two weeks after the request for consultation was received.

(2) Where the qualified entity is from another Member State

or EEA State, the Authority shall treat the list of qualified entities

published by the Commission as conclusive proof of the legal capacity

of the legal entity to present such written application in Malta.

(3) The Authority shall, at the request of a qualified entity

from Malta, communicate to the Commission the name and objects of

such entities and that such qualified entity should be added to the list of

qualified entities so as to facilitate the redress of inter-community

infringements.

(4) Before proceeding for the issue of a compliance order

under article 6, the Authority shall, if it considers it to be possible and

reasonable to do so, seek first to achieve voluntary compliance by a

person licensed under the Act and other persons involved, in accordance

with these regulations, the Act or any other law dealing with consumer

rights and protection.

(5) For the purposes of these regulations, an infringement

occurs when any act is committed contrary to Directive 92/28/EEC as

transposed by the 2005 Regulations.

(1) Where the Authority feels it reasonably appropriate or Issue of compliance

orders.

necessary for the protection of consumers, it may, on a written

application to it by a qualified entity, issue a compliance order against

any person licensed under the Act for one or more of the following

purposes>-

(a) ordering any such person to cease any advertisement of

a medicinal product which the Authority considers to be in breach

of the provisions of the 2005 Regulations<

(b) requiring such person to take any measures specified in

such order, within the time specified in the compliance order to

ensure that such order is complied with<

(c) requiring such person to cease or desist from committing

a breach of these regulations or of the provisions of the Act

regulating advertisements or of the 2005 Regulations.

(2) The Authority shall, when issuing a compliance order

under these regulations -

(a) serve a copy of the compliance order on each person

against whom the order is made<

(b) include with the compliance order, information about

the right to institute an action before the Court of Appeal, in

accordance with regulation 9< and

(c) briefly state the reasons for issuing the compliance order,

which reasons shall be notified to each person against whom the

compliance order is issued and, if any, to the qualifying body on

whose application the compliance order is issued.

(3) No precautionary warrant or other order under any other

law shall be issued by any court or tribunal restraining or restricting the

Authority from issuing a compliance order under such order.

(1) It shall be at the discretion of the Authority whether

or not to issue a compliance order after a written request by a

qualified entity has been made to it in terms of sub- regulation (1) of

regulation 6.

(2) If the Authority decides not to issue a compliance order

after an application has been made to it by a qualified entity, it shall,

within seven days from the date of its decision, notify in writing the

qualified entity and the persons against whom the compliance order is

requested with its decision stating the reasons therefore.

(3) A qualified entity may within fifteen days from the date

of notification upon it of the decision of the Authority not to issue a

compliance order, institute an action before the Court of Appeal for the

issue of an order requiring the Authority to issue a compliance order

under regulation 6. The persons against whom the compliance order is

requested to be made shall be parties to the suit, and it shall be the duty

of the qualified entity to notify such persons accordingly.

(4) In the exercise of its functions and powers under this

Order, the Court of Appeal shall in all cases act as expeditiously as

possible.

A compliance order issued by the Authority shall come into Compliance order to

take immediate

force with immediate effect.

effect.

(1) A person against whom a compliance order has been Appeal from a

compliance order.

made, may, within fifteen days from receipt of notification of the

compliance order, appeal in writing to the Court of Appeal for the

revocation or amendment of the compliance order, giving detailed

grounds for the request. Such appeal may be made only on the following

grounds>-

(a) the Authority has, in its decision wrongly applied any

of the provisions of these regulations< or

(b) the decision of the Authority constitutes an abuse of

discretion or is manifestly unfair.

(2) The Court of Appeal may confirm, change or cancel the

compliance order on any terms or conditions it considers appropriate.

(3) Where an appeal is instituted under sub- regulation (1),

the compliance order shall remain in force unless the Court of Appeal

specifically orders that the compliance order shall be stayed pending

the outcome of the appeal, subject to such conditions and amendments

as it may determine. In any such instance, the Authority may request

the Court of Appeal to make an interim compliance order, ordering that

the compliance order shall, subject to such modifications as the Authority

may suggest, continue in force pending the final determination of the

case instituted in accordance with sub-regulation (1). An interim

compliance order shall expire upon the final determination of the case.

(4) Subject to these regulations, the provisions of the Code

of Organization and Civil Procedure shall, mutatis mutandis, govern Cap.12.

appeals to the Court of Appeal.

The Authority, when issuing a compliance order under

regulation 6, shall not be required to prove>-

(a)

actual loss or damage or

(b) actual recklessness, negligence or fault on the part of

the person against whom the order is made.

(1) The Authority may, for the better information of the

public>-

(a) publish a copy of the compliance order made under

regulation 6 against any such person, in full or in part< or

(b) order any person licensed under the provisions of the

Act to publish a corrective statement in relation to any contravention

of these regulations< or

(c)

take both measures mentioned in paragraph (a) and (b)

above.

(2) Publication in terms of sub-regulation (1) shall be made

at the expense of the against whom the order was issued, in at least two

daily newspapers within seven days from receipt of the notice and shall

be at the expense of the person served with such notice. Where such

publication is not effected as aforesaid, the Authority may proceed to

effect publication itself, in which case it shall have the right to recover

from the person on whom the notice is served, any expenses incurred,

as a civil debt, constituting an executive title for the purposes of Title

VII of Part I of Book Second of the Code of Organization and Civil

Procedure as if payment of the amount of the civil debt has been ordered

by a judgment of a court of civil jurisdiction.

The Authority may in writing authorize any of its employees,

a public or other officer or any other person to perform any of its

functions in relation to the enforcement of these regulations or exercise

any power granted to it under these provisions. Any such authorized

person shall, when required, produce the written authorisation signed

by the Authority.

(1) The Authority may, for the purpose of discharging its

functions under these regulations, require any person to provide any

information in any manner, including by>-

(a)

answering any questions, orally or in writing< or

(b) producing any item or data as aforesaid as the Authority

may consider to be necessary< or

(c) producing any books, documents or other records as the

Authority may consider to be necessary.

(2) Any such person shall promptly comply with any such

request.

(1) A person licensed under the provisions of the Act, shall Failure to comply

with these

be liable to an administrative penalty in terms of regulation 15 if such regulations.

person:ñ

(a)

fails to observe any other provision in these regulations<

(b) fails to comply with a compliance order issued under

these regulations< or

(c) refuses or fails to furnish information as required under

these regulations or else provides false or misleading information.

(2) A person licensed under the provisions of the Act, shall

be liable to an administrative penalty if such person>-

(a) wilfully obstructs, assaults, threatens, resists or interferes

with the Authority or any person delegated by it in terms of

regulation 12 or any public officer in the exercise of his duties

under these regulations or attempts so to do< or

(b) uses threatening, abusive or insulting language to the

Authority or any person delegated by it in terms of regulation 12

or any public officer in the course of duties.

(1) In the event of liability arising in terms of article 14 the Administrative

penalties.

Chief Executive of the Authority may by notice in writing request the

Authority to impose on the person licensed under the provisions of the

Act an administrative penalty in terms of article 100 of the Act and the

procedure laid down in that article shall mutatis mutandis apply.

(1) Nothing in these regulations shall prejudice or limit the Other administrative

sanctions.

exercise of the powers of the Authority to take administrative measures

or impose penalties under the Act, against a person licensed under the

provisions of the Act who has contravened any provisions of these

regulations or has failed to satisfy or comply with any obligation or

condition to which he may be subject under the Act or the 2005

Regulations.

(2) Nothing in these regulations shall be deemed to restrict

or detract from the powers of the Authority under any other law, or

from the powers of the Police under the Criminal Code or any other

law.

(1) Where an order or notice is required or authorised to be

served under these regulations it shall be served in any of the following

manners>-

(a) by delivering it, or by sending it by registered mail to

the person on whom it is to be served at such personís place of

residence, office or place of work< or

(b) in the case of a body corporate or other body of persons,

by delivering it to an officer or servant thereof at the registered

office or any other place of business, or sending it in a registered

letter addressed to any such office.

(2) In any case where it is not reasonably possible to effect

service in any manner stated in sub- regulation (1), service may be

affected by publishing a summary of such notice in the Gazette.

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

€0.75 (Lm0.32)