Veterinary Medicines

The European Commission wants to tackle the public health threat posed by antimicrobial resistance (exacerbated by the prevalence of antibiotics in the food chain) by clarifying the rules that apply to veterinary medicine and medicated feed in the EU.

In addition to ensuring the safety of the food chain, the Commission wants to guarantee the welfare of animals by putting in place clear rules, not only on what medicines and medicated feed can be used, but also on how these medicines are continually monitored.

Two legislative proposals have been put forward. The new measures, presented by the Commission on 10 September 2014, consist of a Proposal for a Regulation on veterinary medicinal products and a Proposal for a Regulation on the manufacturing, placing on the market and use of medicated feed.

These two measures would set up a new regulatory framework on veterinary medicines and medicated feed and would replace the current legislative framework.

Proposal on Veterinary Medicinal Products

Scope

This proposed Regulation sets out rules designed to simplify the manufacture, supply, marketing and usage of veterinary medicines.

Authorisation

Perhaps the most significant change would be the scrapping of the current five-year period of validity and replacing it with unlimited validity. For products of limited market use however (such as veterinary medicines for the treatment and prevention of diseases that occur infrequently, or for rare animal species), medicines would be valid for only three years.

The Regulation would also aim to simplify things by reducing the amount of compulsory information required, and by introducing harmonised pictograms and abbreviations, helping to cut packaging costs.

For generic medicines (such as products that share the same composition of active substances as reference medicinal products), applicants would not be required to prove information on the safety and the efficacy of the product, but instead rely on the data provided by the reference product. For homeopathic medicines, the Regulation would introduce a simplified registration procedure calling for less information.

Another change proposed by the Commission would be the extension of the protection period which would apply to the technical documentation on quality, safety and efficacy provided by the applicant. The protection periods would be:
• 10 years for medicines for cattle, sheep, pigs, chickens, dogs and cats.
• 14 years for antimicrobial products for cattle, sheep, pigs, chickens, dogs and cats.
• 18 years for medicines for bees.
• 14 years for medicines for all other species. 
Generic medicines would not be allowed to be placed on the market before the protection period for the reference product has elapsed.

Procedures

The Commission proposes several procedures that could lead to marketing authorisation.

For all veterinary medicines derived from biotechnology, a centralised procedure would be compulsory. In this case, authorisation would be granted by the Commission and would be valid throughout the EU. This centralised authorisation could be used for other products if no other marketing authorisation has been granted within the EU.

Marketing authorisation could also be granted by a Member State (national marketing authorisation). Authorisation would be granted by the competent national authorities in accordance with the Regulation and would be valid in this Member State.

When no national marketing authorisation has been granted, the applicant would have the possibility to use the decentralised marketing authorisation. In this case, the application should be submitted to a Member State (the ‘reference Member States’) and should list Member States where the applicant wants to obtain a marketing authorisation. If no Member State objects, the reference Member State would grant the authorisation, as well as the other Member States concerned.

Eventually, mutual recognition would apply to marketing authorisations. This means that a national marketing authorisation should be recognised by other Member States. A minimum of six months should however elapse between the first marketing authorisation and the application for a mutual recognition procedure.

Post-Marketing

The Commission proposes to establish a single product database for all authorised veterinary medicines in the EU. This would enable veterinarians to identify the products they need from other Member States.

Post-marketing authorisation measures would include amending marketing authorisations and pharmacovigilance. Pharmacovigilance describes the process of monitoring and investigating adverse events in order to ensure the continuous safety of products once they are authorised. Concerning the possibility of amending a marketing authorisation, the rule would be that only changes that substantially affect product safety or efficacy would require prior authorisation by the competent authorities.

With regard to pharmacovigilance, the Regulation would set out a pharmacoviligance system based on a risk approach. Healthcare professionals and animal holders would be offered different ways of reporting any incident, such as noxious and unintended effect, lack of efficiency or environmental incidents. A Union pharmacovigilance database would be established by the European Medicines Agency.

Supply, Use and Controls

The Regulation would allow the sale of veterinary medicines via the internet, provided that retailers are allowed to supply them in the Member State in which the buyer is established.

In order to tackle the public health threat of antimicrobial resistance (i.e. the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same species), the Regulation would enable the Commission to establish a list of antimicrobial products that cannot be used or which the use is subject to certain conditions.

With regards to inspection systems, the Regulation would allow the Commission to check Member State’s inspection systems in order to ensure that the legislation is enforced consistently.

Proposal on Medicated Feed

Scope

The proposed Regulation would apply to the manufacture, storage, transport, placing on the market and use of medicated feed.

According to the Commission, ‘medicated feed’ should be defined as a mixture of one or more veterinary medicinal products with one or more feeds which is ready to be directly fed to animals without further proceeding. The Regulation would apply to medicated-feed for food-producing animals as well as to medicated feed for non-food producing animals. 

The Regulation would not apply to veterinary medicines which are used as the medicinal component of medicated feed, which are dealt with under the veterinary medicinal product Regulation.

Placing on the Market

When manufacturing, storing, transporting and placing on the market medicated feed, feed business operators would be required to comply with the provisions laid down in Annex I to the Regulation. This Annex provides provisions regarding facilities and equipment, personnel, manufacture, quality control, storage and transport, record keeping, complaints and product recall.

Medicated feed would be allowed to be manufactured only from veterinary medicinal products which are authorised for this purpose. The Regulation would enable the Commission to set up criteria in order to ensure the homogenous manufacturing of feed.

In order to avoid any risk of carry-over (i.e. the transfer of traces of an active substance into non-target feed), the Commission would also be allowed to adopt delegated act to establish specific carry-over limits for active substances. When no specific limits have been set up, the limits would be 1% of the active substance in the last batch of medicated feed product produced before the production of non-target feed for antimicrobial and 3% for other active substance.

With regards to the labelling, manufacturers would for instance be requested to include information on the medicine used in the preparation.

Approval of Establishments

The Regulation would require feed business operators to ensure that establishments under their control are approved by the competent authority. In order to approve establishments, competent authorities should visit the site prior to the starting of any activity in order to ensure that the requirements are met.

Prescription and Use

The supply of medicated feed to animal holders would be subject to the presentation or the possession of a veterinary prescription. This prescription should contain information such as the name of the person allowed to prescribe the medicine, the date, the name of the animal holder, the disease to be treated and the designation of the medicine. The prescription would be valid for a maximum six-month period for non-food producing animals and three weeks for food-producing animals.

Next Steps

The proposals will now be transmitted to the Parliament and the Council and will follow the ordinary legislative procedure (co-decision).