OpenLobby.EU
Explore

CPA Italian Chemical Pharmaceutical Association

CPA ITALY

CPA is an Italian Association of Active Ingredient and Intermediate suppliers, comprising more than 30 manufacturers and distributors who play a key role in the supply of active ingredients to pharmaceutical manufacturers.

Lobbying Activity

Response to Rules on good manufacturing practice for active substances used as starting materials in veterinary medicinal products

18 Feb 2025

COMMISSION IMPLEMENTING REGULATION laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council A. It is recommended to include the following definitons: Active Substances as they are defined in Eudralex Volume 4, Part II as Active Pharmaceutcal Ingredient (API) (or Drug Substance) Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, orprevention of disease or to affect the structure and function of the body B. It is recommended to add under CHAPTER I GENERAL PROVISIONS - Article 1 Subject mater and scope - 7. This Regulaton does not apply to the following actve substances: (e) actve substances as they are defined (as above) in Eudralex Volume 4, Part II as Actve Pharmaceutcal Ingredient (API) (or Drug Substance) when used as raw material, in the producton of intermediates or actve substances. Comment related to bullet B. In the manufacturing of an actve substance, as defined (as above) in Eudralex Volume 4, Part II as Actve Pharmaceutcal Ingredient (API) (or Drug Substance), actve substances may be used as raw material for further processing or as adjuvant in the synthesis. Examples are here provided, but they are not limited to: inorganic salts, sugars, amino acids, vitamins, food additves or other simple molecules having a potential pharmacological activity. Given the primary use of such actuve substances in the active substance manufacturing process and considering that they are subject to multiple chemical transformations to obtain the final active substance, manufacturing of such active substances is not required to be performed applying the full good manufacturing practice requirements set out in this Regulation. C. Note: It is considered essential for manufacturers who manage the production of both active substances to be used in human medicinal products and active substances to be used in veterinary medicinal products to have a single Quality System. Therefore, based on the content of this Regulation, where principles have been implemented, manufacturers of active substances for both veterinary use and human use can refer to Pharmaceutical Quality System and GMP as stated in ICH Q10 and ICH Q7 respectively.
Read full response