The Spanish Ministry of Health has adopted a new draft of the Royal Decree on Industrially Manufactured Veterinary Medicinal Products ("Royal Decree on Industrially Manufactured Veterinary Medicinal Products"). The new draft establishes specific provisions for the application in Spain of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products ("Regulation 2019/6"), which, together with Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, represents the legislative framework adopted in the middle of the European One Health Action Plan against antimicrobial resistance.
The new draft, still in the legislative pipeline, aims to regulate industrially manufactured veterinary medicinal products or the manufacture of which involves an industrial process, and in particular: (a) the requirements of the application for marketing authorization; (b) the procedures for authorization, variations to the conditions of authorization, suspension and revocation of the marketing authorization; (c) the entry in the registry of medicinal products; (d) special conditions for certain types of medicinal products; (e) the obligations of the marketing authorization holder and the simplified registry of veterinary medicinal products; (f) pharmacovigilance; (g) parallel trade; and (h) clinical investigations involving veterinary medicinal products.
This legislative initiative completes the legislation in this area by redefining certain activities that needed an update, such as pharmacovigilance, the obligations of health professionals and clinical research; and by regulating ex novo certain areas such as medicinal products for ornamental fish and other species and parallel trade.
On 25 May 2021, the Spanish Ministry of Health closed the public hearing phase of the Royal Decree on Industrially Manufactured Veterinary Medicinal Products, which repeals Royal Decree 1246/2008 of 11 July, regulating the procedure for the authorization, registration and pharmacovigilance of industrially manufactured veterinary medicinal products, and certain articles of Royal Decree 109/1995 of 27 January on veterinary medicinal products and Royal Decree 1800/2003 of 26 December regulating medical gases.
This initiative represents the legislative complement of Regulation 2019/6. Therefore, there are some provisions of Regulation 2019/6 that are directly applicable in the Spanish system, such as the marketing authorization applications and accompanying documentation, the marketing authorization procedures, the procedure to be followed for variations to marketing authorizations, the procedure for re-examination of the marketing authorization applications, the procedure for harmonization of the summaries of product characteristics and the procedure for referral in the interest of the Union.
The main changes that will be introduced by the Royal Decree on Industrially Manufactured Veterinary Medicinal Products are the following:
1. Scope. Besides what is established in Regulation 2019/6, the project also applies to herbal medicinal products and radiopharmaceuticals.
2. Simplified registry and distribution of samples. The project includes the development of the concept of simplified registration, which is distinguished from marketing authorization; maintenance on the market, with the obligations that apply to marketing authorization and registration holders; and advertising, where the distribution of samples is regulated as well. Specifically, the distribution of samples requires prior request to the Spanish Agency of Medicinal Products and Medical Devices (AEMPS), with the distribution of samples only being permitted during the first year of commercialization and with a maximum amount of five samples for vets and 200 in total.
3. Special medicines. Medicinal products not subject to veterinary prescription and intended for certain animal species held exclusively as pets will fall under the simplified registration procedure. The list includes aquarium or pond fish, ornamental fish, caged birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits.
4. Pharmacovigilance. The new draft sets a maximum period of 15 days for healthcare professionals to report suspected adverse events and a minimum period of five years for healthcare professionals to retain clinical information on suspected adverse events. It also reduces the obligations for marketing authorization and registry holders.
5. Obligations corresponding to the marketing authorization or registration holder. The project establishes a new period of 10 working days in order to notify any suspicions of a medicinal product's quality defects and the obligation to notify the AEMPS of any suspicion of a possible shortage of a medicinal product.
6. Variation of marketing authorization at the request of a party. The procedure for the variation of marketing authorizations at the request of a party refers to the procedure provided in Regulation (EU) 2019/6, Chapter IV, Section 3.
Parallel trade. For the first time, the project lays out the authorization procedure to be followed for the parallel trade of veterinary medicinal products, as well as the obligations of the wholesale distributor. In particular, the wholesale distributor is required to hold an authorization in order to distribute in Spain veterinary medicinal products from another Member State that share a common origin with those authorized and registered in the registry of medicinal products. The wholesale distributor's obligations include reporting suspected adverse events and defects in the quality of the medicinal product. Finally, a wholesale distributor who is not the marketing authorization holder in Spain must notify the marketing authorization holder in Spain of their intention to distribute the medicinal product at least one month before submitting the corresponding application for parallel trade, and provide them, at their request, with a sample of the repackaged medicinal product so that they can check that the presentation for sale does not harm the brand's reputation.