Q&A: Classification of centrally authorised veterinary medicinal products

The classification of medicinal products for veterinary use is governed by Directive 2001/82/EC. Regulation (EC) No. 726/2004 lays down procedures for the authorisation and supervision of medicinal products for veterinary use which are authorised by the Union (centrally authorised products) and Article 39 (9) of this regulation requires that the CVMP shall propose the conditions for the prescription and use of centrally authorised products.

In accordance with Article 67 of Directive 2001/82/EC, certain veterinary medicinal products require a veterinary prescription as outlined in question 4. A prescription is also required for food-producing animals unless an exemption has been granted in accordance with Directive 2006/130/EC.

References

• Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
• Directive 2001/82/EC, as amended, on the Community code relating to veterinary medicinal products
• Directive 2006/130/EC implementing Directive 2001/82/EC as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription

This guidance applies to all centrally authorised veterinary medicinal products and concerns changes in classification from prescription-only to non-prescription for veterinary medicinal products authorised in accordance with Regulation (EC) 726/2004 of the European Parliament and of the Council (and its predecessor Council Regulation (EEC) No. 2309/93).

Article 85(3) of Directive 2001/82/EC prohibits the advertising to the general public of veterinary medicinal products which are only available on prescription. It is therefore anticipated that centrally authorised products which have changed classification to non-prescription status could be directly advertised to the general public. The monitoring of advertising, however, remains the responsibility of the competent authorities of the Member States.

In accordance with Article 67 of Directive 2001/82/EC, veterinary medicinal products require a veterinary prescription where:

1. The product is subject to official restrictions on supply or use, such as the restrictions resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances, or
2. There are restrictions on the use of the product resulting from Union law, or
3. The product is subject to official restrictions on supply or use, or
4. The product requires special precautions to be taken by the veterinary surgeon in order to avoid unnecessary risk to the target animal, the user or the environment, or
5. A precise diagnosis is required, or
6. The product is an official formula, or
7. The active substance contained in the product has been authorised for use in a veterinary medicinal product for less than five years.

Each of the above criteria will influence the classification of a veterinary medicinal product, unless an exemption has been granted.

Given that Directive 2006/130/EC has established criteria for exempting certain veterinary medicinal products for food producing species from the requirements for a veterinary prescription and that it is considered that these criteria apply equally to products for non-food producing species, it is appropriate to maintain consistency and utilise the same criteria when considering a change in classification of centrally authorised products.

The change to non-prescription status is considered appropriate for a centrally authorised veterinary medicinal product when all the conditions listed below are met:

1. The administration of veterinary medicinal products is restricted to formulations requiring no particular knowledge or skill in using the products;
2. The veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal or animals treated, to the person administering the product or to the environment;
3. The summary of product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effects deriving from its correct use;
4. Neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent serious adverse reaction reporting;
5. The summary of product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;
6. The veterinary medicinal product is not subject to special storage conditions;
7. There is no risk for consumer safety as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;
8. There is no risk to human or animal health as regards the development of resistance to antimicrobials or anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly. A precise diagnosis prior to treatment (see question 3) might not be required for veterinary medicinal product with certain indications such as commonly treated parasitic diseases.

In addition to appearing in Annex II of the Commission Decision, the legal status appears in the label text which is included in Annex IIIA of the Commission Decision. However, the expression of the legal status in the label text in the Commission Decision is limited to one main classification following the criteria of Article 67 of Directive 2001/82/EC (e.g. "veterinary medicinal product subject to prescription") which is common to all EEA countries.

With regard to the classification of a product having different pharmaceutical forms or target species, it is possible that a prescription is only required for certain SPCs of the centrally authorised product, e.g. a certain pharmaceutical form or target species. The CVMP will evaluate each application for a change in the classification on a case-by-case basis and decide appropriately.

The MAH should submit a type II variation to the EMA requesting a change in the classification of the veterinary medicinal product. The CVMP reviews the request and formulates an opinion recommending the classification for the product. Such an application can be made for all presentations of a centrally authorised veterinary medicinal product or for individual SPCs (e.g. target animal species or pharmaceutical form). The application should be accompanied by a justification for a change in the classification together with supporting documentation, as appropriate.

However, once granted, a change in classification may be further reconsidered if necessary on the basis of new safety information. Without prejudice to the opinion relaxing the classification of the veterinary medicinal product and where information is brought to the CVMP's attention, the CVMP may decide that the product should revert to prescription-only status and will require the MAH to submit a type II variation to effect this.

References

• Q&A: Type II variations

The MAH is required to demonstrate that the product meets the criteria for a change in classification.

The application for the change in classification should consist of:

• A report providing a critical analysis of the benefits and risks of the proposed use of the product without prescription, taking into account all the criteria listed in question 5;
• The results of periodic safety update report assessment, any post-authorisation surveillance studies and information on, and a critical assessment of, any adverse reactions during the use of the product under prescription-only conditions;
• Consideration of the potential for, and consequences of, drug interactions in animals or humans with other prescription and non-prescription veterinary medicines.
• Documents amended as a result of the variation to change the classification of the veterinary medicinal product.

References

• Q&A: Type II variations

Sub-categories of classification such as for the distribution of a non-prescription veterinary medicinal product remain subject to the national requirements of the Member State where the product is marketed. One or more of the sub-categories may be used for one veterinary medicinal product.Even if the legislation in a Member State does not provide for certain sub-categories, the MAH is under an obligation to ensure that the veterinary medicinal product is marketed, all over the Union, subject to the conditions laid down in Annex II of the Commission Decision.

These sub-categories, where required, should be indicated on the outer packaging of a centrally authorised product in the blue box area.

The CVMP will review each request on a case-by-case basis and formulate an opinion recommending the classification for the product concerned.

Requests for a change in classification will normally be evaluated according to a 60-day type II variation timetable.

References

• Q&A: Type II variations