HERBAL MEDICINAL PRODUCTS REGULATIONS

SUBSIDIARY LEGISLATION 458.44

HERBAL MEDICINAL PRODUCTS REGULATIONS

30th October, 2005

LEGAL NOTICE 379 of 2005, as amended by Legal Notice 370 of 2012.

(1) The title of these regulations is the Herbal Medicinal

Products Regulations.

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

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

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),

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;

"traditional herbal medicinal product" means a herbal medicinal

product that fulfils the conditions laid down in regulation 3.

(1) Herbal medicinal products shall be subject to a

simplified registration procedure, hereinafter referred to as

traditional 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 subregulation (1), 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), 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,

regulation 22 of the Medicines Regulations shall apply by analogy

to registrations granted in accordance with regulation 3, provided

that

(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

regulation 5(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 subregulation (1),

registrations pursuant to that subregulation 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) The following provisions shall apply, by analogy, to

traditional use registration granted under these regulations

(a) articles 2(a), 2(b), 28(1), (2) and (6), 102, 104A(1) and

110(4) of the Medicines Act;

(b) regulations 4(1)(a) and (b), 9, 12, 15(1) and (2), 18(1),

(2) and (3), 19, 20, 26, 27, 28, 29 and 30 of the

Medicines (Marketing Authorisation) Regulations;

(c) the Good Manufacturing Practice in respect of

Medicinal

Products,

Active

Substances

and

Investigational Medicinal Products for Human Use

Regulations;

(d) the Manufacture and Importation of

Medicinal

Products for Human Use Regulations; and

(e) the Pharmacovigilance 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, 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

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.

For the traditional herbal medicinal products which are

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.