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Ireland (proposed legislation): Implementation of Directive 2001/83/EC as amended 

Category: Ireland

Article 1(5) [Definition of homeopathic medicinal product] 

Regulation 3, S.I. No. of 2007 Medicinal Products (Control of Placing on the Market)
Regulations 2007 (Draft)
(1) In these Regulations:

(…)

‘homeopathic medicinal product’ means any medicinal product, which may contain a number of principles, prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in an EEA State. The term also includes anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method;

(…)

Category: Ireland

Article 13 [‘Old products’] 

Regulation 24, S.I. No. of 2007 Medicinal Products (Control of Placing on the Market)
Regulations 2007 (Draft)

(…)

(5) (a) The provisions of these Regulations shall not apply until 30 April 2011 to homeopathic medicinal products to which Regulation 11 applies and which were on the market in the State on the coming into force of these Regulations.
(b) Notwithstanding clause (1) of this subparagraph and with a view to ensuring that marketing authorisations are held by the 30 April 2011, the Board may establish and publish dates by which applications in accordance with these Regulations, for such authorisations shall be made in respect of such products or classes of such products, and the Board shall consider each such application as provided for in these Regulations. 

Category: Ireland

Article 14 [Special simplified registration procedure] 

Regulation 11, S.I. No. of 2007 Medicinal Products (Control of Placing on the Market) Regulations 2007 (Draft)

(…)

(2) For the purposes of obtaining an authorisation in accordance with this Regulation and subject to paragraph (3), the applicant shall demonstrate to the satisfaction of the Board –

(…)

(e) that the safety of the homeopathic medicinal product has been established in the manner set out in paragraph (3).

(3) For the purpose of this Regulation and subject to subparagraph (4), the safety of the homeopathic medicinal product shall be demonstrated -
(a) by reference to relevant published literature or original data having regard to the proposed route of administration and the dilution involved; or
(b) in the case of stocks derived from substances commonly used in food, by means of a statement setting out the homeopathic nature of the product and the absence of any change to the route of exposure for the substance concerned; or
(c) in the case of an active principle used in allopathic medicinal products, by establishing that the dilution of the stocks is at least 1 in 10,000 of the mother tincture or not more than one hundredth of the smallest dose of the said active principle as used in allopathy; or
(d) by establishing that the medicinal product contains not more than one part per 10,000 of the mother tincture.

(4) In regard to the active principles referred to in subparagraphs (3)(c) and (d), the Board may refuse to grant an authorisation where it is satisfied that the active principle concerned is toxic and as such would present concerns in regard to the safety of the product. For the purposes of this subparagraph, the Board may publish and update from time to time a list of the substances that it considers to be in this category.

Category: Ireland

Article 15 [Documents special simplified registration procedure] 

Category: Ireland

Article 16 [Marketing authorisation/Territory specific rules] 

Regulation 11, S.I. No. of 2007 Medicinal Products (Control of Placing on the Market) Regulations 2007 (Draft)
(1) Notwithstanding the provisions of Regulations 9 and 10 insofar as those provisions relate to the requirements for pre-clinical tests and clinical trials, the Board may grant a marketing authorisation in respect of a homeopathic medicinal product other than a product referred to in Article 14.1 of the 2001 Directive.

(2) For the purposes of obtaining an authorisation in accordance with this Regulation and subject to paragraph (3), the applicant shall demonstrate to the satisfaction of the Board –
(a) that the product is a homeopathic medicinal product which conforms with the principles and characteristics of homeopathy as practised in the State;
(b) that the indication sought is appropriate to such a homeopathic medicinal product;
(c) that any such indication shall be suitable for use without the intervention of a registered medical practitioner for diagnostic purposes or for prescription or for the monitoring of treatment;
(d) that the efficacy of the product shall be established on the basis of evidence that the particular class of homeopathic medicinal product has been in use in the State as a homeopathic treatment for the indication sought; and
(e) that the safety of the homeopathic medicinal product has been established in the manner set out in paragraph (3).

(3) For the purpose of this Regulation and subject to subparagraph (4), the safety of the homeopathic medicinal product shall be demonstrated -
(a) by reference to relevant published literature or original data having regard to the proposed route of administration and the dilution involved; or
(b) in the case of stocks derived from substances commonly used in food, by means of a statement setting out the homeopathic nature of the product and the absence of any change to the route of exposure for the substance concerned; or
(c) in the case of an active principle used in allopathic medicinal products, by establishing that the dilution of the stocks is at least 1 in 10,000 of the mother tincture or not more than one hundredth of the smallest dose of the said active principle as used in allopathy; or
(d) by establishing that the medicinal product contains not more than one part per 10,000 of the mother tincture.

(4) In regard to the active principles referred to in subparagraphs (3)(c) and (d), the Board may refuse to grant an authorisation where it is satisfied that the active principle concerned is toxic and as such would present concerns in regard to the safety of the product. For the purposes of this subparagraph, the Board may publish and update from time to time a list of the substances that it considers to be in this category.

Category: Ireland

Article 28 & Article 39 [Mutual recognition procedure/Decentralised procedure] 

Category: Ireland

Article 68 & Article 69 [Labelling & package leaflet] 

Regulation 11, S.I. No. of 2007 Medicinal Products (Control of Placing on the Market) Regulations 2007 (Draft)

(…)

(5) A homeopathic medicinal product that is placed on the market on foot of a marketing authorisation granted in accordance with this Regulation shall, in addition to compliance with the requirements of Regulation 16 (relating to labelling and package leaflets), be presented in such a manner as to show -
(a) that the product is a homeopathic medicinal product in respect of which an authorisation has been granted in accordance with this Regulation;
(b) that any evidence of efficacy on the part of the product has not been based on the outcome of clinical trials;
(c) that use of the product is only intended for the symptomatic relief of the condition to which the indication specified relates; and (d) that the user is advised to consult a doctor or other healthcare professional if the symptoms persist.

Regulation 16, S.I. No. of 2007 Medicinal Products (Control of Placing on the Market) Regulations 2007 (Draft)
(1) Without prejudice to the provisions of Regulation 17 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), a person responsible for placing a medicinal product on the market, which is the subject of a Community marketing authorisation or of a marketing authorisation, certificate of registration or certificate of traditional-use registration, shall not sell, supply or procure the sale or supply of such product unless –
(a) the labelling and any package leaflet accompanying the product are in compliance with Title V of the 2001 Directive; and
(b) except where all the information required to be included in the said package leaflet is directly conveyed on the outer packaging or immediate packaging of the product, the packaging contains a package leaflet in compliance with Title V of the 2001 Directive.

(…)

Category: Ireland

Article 100 [Advertising] 

Category: Ireland