Herbal Medicinal Products Regulations, 2005

L.N. 379 of 2005

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Herbal 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 Herbal Medicinal

Products Regulations, 2005.

(2) The scope of these regulations is to transpose

Directive 2001/83/EC as amended by Directive 2004/24/EC.

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

October, 2005.

For the purposes of these regulations –

“the Committee” means the Committee for Herbal

Medicinal Products set up within the European Medicines

Agency, established by Regulation (EC) 726/2004;

“corresponding product” as referred to in Regulation

5(1)(c) of these regulations, means a product which is

characterised by having the same active ingredients, irrespective

of the excipients used, the same or similar intended purpose,

equivalent strength and posology and the same or similar route

of administration as the medicinal product applied for;

“the Directive” means Directive 2001/83/EC as amended

by Directive 2004/24/EC;

“herbal medicinal product” means any medicinal product,

exclusively containing as active ingredients one or more herbal

substances or one or more herbal preparations, or one or more

such herbal substances in combination with one or more such

herbal preparations;

“herbal preparations” means preparations obtained by

subjecting herbal substances to treatments such as extraction,

distillation, expression, fractionation, purification,

concentration or fermentation. These include comminuted or

powdered herbal substances, tinctures, extracts, essential oils,

expressed juices and processed exudates;

“herbal substances” means all mainly whole, fragmented

or cut plants, plant parts, algae, fungi, lichen in an unprocessed

but usually dried form, but sometimes fresh. Certain exudates

that have not been subjected to a specific treatment are also

considered to be herbal substances. Herbal substances are

precisely defined by the plant part used and the botanical name

according to the binomial system (genus, species, variety and

author);

“the Medicines Regulations” means the Medicines

(Marketing Authorisation) Regulations, 2005;

“traditional herbal medicinal product” means a herbal

medicinal product that fulfils the conditions laid down in

regulation 3 of these regulations.

(1) Herbal medicinal products shall be subject to a Simplified

registration

simplified registration procedure, hereinafter referred to as traditional procedure.

use registration, provided they fulfil all of the following criteria

(a) they have indications exclusively appropriate to

traditional herbal medicinal products which, by virtue of their

composition and purpose, are intended and designed for use

without the supervision of a medical practitioner for diagnostic

purposes or for prescription or monitoring of treatment;

(b) they are exclusively for administration in accordance

with a specified strength and posology;

(c) they are an oral, external and, or inhalation

preparation;

(d) the period of traditional use as laid down in regulation

5 (1)(c) has elapsed;

(e) the data on the traditional use of the medicinal product

are sufficient; in particular the product proves not to be harmful

in the specified conditions of use and the pharmacological

effects or efficacy of the medicinal product are plausible on the

basis of long-standing use and experience.

(2) Notwithstanding the definition of herbal medicinal

product, the presence in the herbal medicinal product of vitamins or

minerals, for the safety of which there is well-documented evidence,

shall not prevent the product from being eligible for registration in

accordance with sub-regulation (1) of this regulation, provided that

the action of the vitamins or minerals is ancillary to that of the herbal

active ingredients regarding the specified claimed indication or

indications.

(3) However, in cases where the Licensing Authority,

hereinafter referred to as “the Authority”, judges that a traditional

herbal medicinal product fulfils the criteria for a marketing

authorisation in accordance with regulation 4(1) of the Medicines

Regulations, or registration pursuant to regulation 10(3) of the

Medicines Regulations, the provisions of this regulation shall not

apply.

(1)

To qualify for registration the applicant and

registration holder shall be established in the Community.

(2) In order to obtain traditional use registration, the

applicant shall submit an application to the Authority.

(1)

The application shall be accompanied by

(a)

the particulars and documents>

(i) referred to in regulation 5 (1)(c)(i) to (ix), (xi)

and (xii) of the Medicines Regulations<

(ii) the results of the pre-clinical (toxicological and

pharmacological) tests referred to in regulation 5(1)(c)(x)

of the Medicines Regulations<

(iii) the summary of product characteristics, without

the data specified in regulation 8(1)(d) of the Medicines

Regulations<

(iv) in case of combinations of herbal medicinal

products, or as in regulation 3(2) hereof, the information

referred to in regulation 3(1)(e) relating to the combination

as such< if the individual active ingredients are not

sufficiently known, the data shall also relate to the

individual active ingredients<

(b) any authorisation or registration obtained by the

applicant in another Member State, or in a third country, to

place the medicinal product on the market, and details of any

decision to refuse to grant an authorisation or registration,

whether in the Community or a third country, and the reasons

for any such decision<

(c) bibliographical or expert evidence to the effect that

the herbal medicinal product in question, or a corresponding

product has been in medicinal use throughout a period of at

least thirty years preceding the date of the application, including

at least fifteen years within the Community. At the request of

the Authority, the Committee shall draw up an opinion on the

adequacy of the evidence of the long-standing use of the product,

or of the corresponding product. The Authority shall submit

relevant documentation supporting the referral<

(d) a bibliographic review of safety data together with

an expert report, and where required by the Authority upon

additional request, data necessary for assessing the safety of

the medicinal product<

(e) Annex I of the Directive shall apply by analogy to

the particulars and documents specified in paragraph (a).

(2) The requirement to show medicinal use throughout

the period of thirty years, shall be satisfied even where the marketing

of the product has not been based on a specific authorisation or if

the number or quantity of ingredients of the medicinal product has

been reduced during that period.

(3) Where the product has been used in the Community

for less than fifteen years, but is otherwise eligible for simplified

registration, the Authority shall refer the product to the Committee

with all the relevant documentation supporting the referral.

(1) Without prejudice to the setting up of the Committee, Application of

regulation 22 of

regulation 22 of the Medicines (Marketing Authorisation) the Medicines

Regulations, shall apply by analogy to registrations granted in (Marketing

Authorisation)

accordance with regulation 3 of these regulations, provided that: Regulations.

(a) a Community herbal monograph has been established

by the Committee, or

(b) the herbal medicinal product consists of herbal

substances, preparations or combinations thereof contained in

the list referred to in Article 16f of the Directive.

(2) For other herbal medicinal products as referred to in

regulation 3, the Authority shall, when evaluating an application for

traditional-use registration, take due account of registrations granted

by another Member State in accordance with chapter 2a of the

Directive.

(1) Traditional use registration shall be refused if the

application does not comply with the conditions set by these

regulations or if at least one of the following conditions is fulfilled

(a) the qualitative and, or quantitative composition is not

as declared<

(b) the indications do not comply with the conditions laid

down in regulation 3<

(c)

the product could be harmful under normal conditions

of use<

(d) the data on traditional use are insufficient, especially

if pharmacological effects or efficacy are not plausible on the

basis of long-standing use and experience<

(e) the pharmaceutical quality is not satisfactorily

demonstrated.

(2) The Authority shall notify the applicant, the

Commission and any competent authority that requests it, of any

decision they take to refuse traditional use registration and the

reasons for the refusal.

(1) If an application for traditional use registration relates

to a herbal substance, preparation or a combination thereof contained

in the list established in accordance with the procedure referred to

in Article 121(2) of the Directive, the data specified in regulation5

(1)(b)(c) and (d) need not be provided. Regulation 7(1)(c) and (d)

shall not apply.

(2) If a herbal substance, preparation or a combination

thereof ceases to be included in the list referred to in sub-regulation

(1), registrations pursuant to that sub-regulation for herbal medicinal

products containing such substance shall be revoked unless the

particulars and documents referred to in regulation 5(1) are submitted

within three months.

(1) Articles 3(1) and (2), 4(4), 6(1), 12, 17(1), 19, 20, 23, Application of

Articles.

24, 25, 40 to 52, 70 to 85, 101 to 108, 111(1) and (3), 112, 116 to

118, 122, 123, 125, 126, second subparagraph, and 127 of the

Directive, and also as Directive 2003/94/EEC, shall apply by

analogy to traditional use registration granted under these regulations.

(2) In addition to the requirements laid down by

regulations 2 to 10 of the Medicinal Products (Labelling and

Packaging) Regulations, 2005 any labelling and user package leaflet

shall contain a statement to the effect that

(a) the product is a traditional herbal medicinal product

for use in specified indication or indications exclusively based

upon long-standing use; and

(b) the user should consult a doctor or a qualified health

care practitioner if the symptoms persist during the use of the

medicinal product or if adverse effects not mentioned in the

package leaflet occur.

(3) In addition to the requirements laid down by the

Medicinal Products (Advertising) Regulations 2005, any

advertisement for a medicinal product registered under these

regulations shall contain the following statement: “Traditional herbal

medicinal product for use in specified indication or indications

exclusively based upon long-standing use”.

(1) When Community herbal monographs have been Herbal

monographs.

established by the Committee, they shall be taken into account by

the Authority when examining an application. Where no such

Community herbal monograph has yet been established, other

appropriate monographs, publications or data may be referred to.

(2) When new Community herbal monographs are

established, the registration holder shall consider whether it is

necessary to modify the registration dossier accordingly. The

registration holder shall notify any such modification to the Authority.

B

Products already

For the traditional herbal medicinal products which are

on market.

already on the market on the entry into force of these regulations,

the Authority shall apply the provisions of these regulations within

seven years after their entry into force.

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