L.S. 458.44 Regolamenti dwar Prodotti ta' Ħxejjex Mediċinali

(1)The title of these regulations is the Herbal Medicinal Products Regulations. Title and scope.

(2)The scope of these regulations is to transpose Directive 2001/83/EC as amended by Directive 2004/24/EC. 2. For the purposes of these regulations - Interpretation. "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. S.L. 458.34 1 2 [ S.L.458.44 Simplified registration procedure. HERBAL MEDICINAL PRODUCTS 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: (

1. 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; (
2. b)they are exclusively for administration in accordance with a specified strength and posology; (
3. c)they are an preparation; oral, external and, or inhalation (
4. d)the period of traditional use as laid down in regulation 5

(1)(

1. c)has elapsed; (
2. 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. Application for registration. 4.

(1)To qualify for registration the applicant registration holder shall be established in the Community. and

(2)In order to obtain traditional use registration, the applicant shall submit an application to the Authority. Particulars to accompany the application. 5.

(1)The application shall be accompanied by: (

1. a)the particulars and documents: (
2. i)referred to in regulation 5

(1)(c)(

1. i)to (ix), (
2. xi)and (xii) of the Medicines Regulations; (
3. ii)the results of the pre-clinical (toxicological and pharmacological) tests referred to in regulation 5

(1)(c)(x) of the Medicines Regulations; HERBAL MEDICINAL PRODUCTS [ S.L.458.44 3 (iii) the summary of product characteristics, without the data specified in regulation 8

(1)(

1. d)of the Medicines Regulations; (
2. iv)in case of combinations of herbal medicinal products, or as in regulation 3

(2), the information referred to in regulation 3

(1)(

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; (
2. 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; (
3. 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; (
4. 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; (
5. 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. 6.

(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: (

1. a)a Community herbal monograph has been established by the Committee, or (
2. b)the herbal medicinal product consists of herbal Application of regulation 22 of the Medicines Regulations. 4 [ S.L.458.44 HERBAL MEDICINAL PRODUCTS 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. Refusal of traditional use registration. 7.

(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: (

1. a)the qualitative and, or quantitative composition is not as declared; (
2. b)the indications do not comply with the conditions laid down in regulation 3; (
3. c)the product could be harmful under normal conditions of use; (
4. 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; (
5. e)the pharmaceutical demonstrated. quality is not satisfactorily

(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. List of herbal substances. 8.

(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), (

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

(1)(

1. c)and (
2. 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. Application of Articles. Amended by: L.N. 370 of 2012. Cap. 458. S.L. 458.34 S.L. 458.42 9.

(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; (

1. c)the Good Manufacturing Practice in respect of Medicinal Products, Active Substances and HERBAL MEDICINAL PRODUCTS [ S.L.458.44 Investigational Medicinal Products for Human Use Regulations; (
2. d)the Manufacture and Importation of Products for Human Use Regulations; and Medicinal (
3. 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: S.L. 458.36 S.L. 458.35 S.L. 458.33 (

1. a)the product is a traditional herbal medicinal product for use in specified indication or indications exclusively based upon long-standing use; and (
2. 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". S.L. 458.34 10.

(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. Herbal monographs.

(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. 11. 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. Products already on market. 5