LegalizeCommission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)
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| V.5.1. | Quality (Part 2) The provisions of Section II.2. Part 2 shall apply to the documents for authorisation of homeopathic veterinary medicinal products referred to in Article 85(2) with the following modifications. | |
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| V.5.2. | Terminology The Latin name of the homeopathic stock described in the marketing authorisation application dossier shall be in accordance with the Latin title of the European Pharmacopoeia or, in absence thereof, of an official pharmacopoeia of a Member State. Where relevant the traditional name(s) used in each Member State shall be provided. | |
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| V.5.3. | Control of starting materials The particulars and documents on the starting materials, that is to say, all of the materials used including raw materials and intermediates up to the final dilution to be incorporated into the finished authorised homeopathic veterinary medicinal product, accompanying the application, shall be supplemented by additional data on the homeopathic stock. The general quality requirements shall apply to all of the starting and raw materials as well as intermediate steps of the manufacturing process up to the final dilution to be incorporated into the finished homeopathic product. Where a toxic component is present, this shall be controlled, if possible, in the final dilution. If this is not possible because of the high dilution, the toxic component shall normally be controlled at an earlier stage. Every step of the manufacturing process from the starting materials up to the final dilution to be incorporated into the finished product shall be fully described. Where dilutions are involved, those dilution steps shall be done in accordance with the homeopathic manufacturing methods laid down in the relevant monograph of the European Pharmacopoeia or, in absence thereof, in an official pharmacopoeia of a Member State. | |
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| V.5.4. | Control tests on the finished medicinal product The general quality requirements shall apply to the homeopathic finished veterinary medicinal products. Any exception shall be duly justified by the applicant. Identification and assay of all the toxicologically relevant constituents shall be carried out. If justified that identification and/or an assay on all the toxicologically relevant constituents is not possible, for example, due to their dilution in the finished medicinal product the quality shall be demonstrated by complete validation of the manufacturing and dilution process. | |
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| V.5.5. | Stability tests The stability of the finished product shall be demonstrated. Stability data from the homeopathic stocks are generally transferable to dilutions/potentisations obtained thereof. If no identification or assay of the active substance is possible due to the degree of dilution, stability data of the pharmaceutical form may be considered. | |
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| V.5.6. | Safety documentation (Part 3) Part 3 shall apply to homeopathic veterinary medicinal products referred to in Article 4(10) of this Regulation with the following specification, without prejudice to the provisions of Commission Regulation (EU) No 37/2010 9 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin. Any missing information shall be justified, for example, justification shall be given as to why demonstration of an acceptable level of safety may be supported, even where some studies are lacking. |
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Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28).
Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10).
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).
Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, p. 5).
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
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