Applications for limited markets
1. By way of derogation from point (b) of Article 8(1), the applicant shall not be required to provide the comprehensive safety or efficacy documentation required in accordance with Annex II, if all of the following conditions are met:
(a)
the benefit of the availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;
(b)
the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.
2. Where a veterinary medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of safety or efficacy has been conducted due to the lack of comprehensive safety or efficacy data.
Validity of a marketing authorisation for a limited market and procedure for its re-examination
1. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be valid for a period of five years.
2. Before the expiry of the five-year period of validity referred to in paragraph 1 of this Article, marketing authorisations for a limited market granted in accordance with Article 23 shall be re-examined on the basis of an application from the holder of that marketing authorisation. That application shall include an updated benefit-risk assessment.
3. A holder of a marketing authorisation for a limited market shall submit an application for a re-examination to the competent authority that granted the authorisation or to the Agency, as applicable, at least six months before the expiry of the five-year period of validity referred to in paragraph 1 of this Article. The application for re-examination shall be limited to demonstrating that the conditions referred to in Article 23(1) continue to be fulfilled.
4. When an application for re-examination has been submitted, the marketing authorisation for a limited market shall remain valid until a decision has been adopted by the competent authority or the Commission, as applicable.
5. The competent authority or the Agency, as applicable, shall assess applications for a re-examination and for an extension of the validity of the marketing authorisation.
On the basis of that assessment, if the benefit-risk balance remains positive, the competent authority or the Commission, as applicable, shall extend the validity of the marketing authorisation by additional periods of five years.
6. The competent authority or the Commission, as applicable, may at any time grant a marketing authorisation valid for an unlimited period of time in respect of a veterinary medicinal product authorised for a limited market, provided that the holder of the marketing authorisation for a limited market submits the missing data on safety or efficacy referred to in Article 23(1).
Applications in exceptional circumstances
By way of derogation from point (b) of Article 8(1), in exceptional circumstances related to animal or public health, an applicant may submit an application which does not meet all requirements of that point, for which the benefit of the immediate availability on the market of the veterinary medicinal product concerned to the animal or public health outweighs the risk inherent in the fact that certain quality, safety or efficacy documentation has not been provided. In such a case, the applicant shall be required to demonstrate that for objective and verifiable reasons certain quality, safety or efficacy documentation required in accordance with Annex II cannot be provided.
Terms of the marketing authorisation in exceptional circumstances
1. In the exceptional circumstances referred to in Article 25, a marketing authorisation may be granted subject to one or more of the following requirements for the marketing authorisation holder:
(a)
a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;
(b)
a requirement to notify to the competent authorities or the Agency, as applicable, of any adverse event relating to the use of the veterinary medicinal product;
(c)
a requirement to conduct post-authorisation studies.
2. Where a veterinary medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety or efficacy has been conducted due to the lack of comprehensive quality, safety or efficacy data.
Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination
1. By way of derogation from Article 5(2), a marketing authorisation in exceptional circumstances shall be valid for a period of one year.
2. Before the expiry of the one-year period of validity referred to in paragraph 1 of this Article, marketing authorisations granted in accordance with Articles 25 and 26 shall be re-examined on the basis of an application from the holder of that marketing authorisation. That application shall include an updated benefit-risk assessment.
3. A holder of a marketing authorisation in exceptional circumstances shall submit an application for re-examination to the competent authority that granted the authorisation or to the Agency, as applicable, at least three months before the expiry of the one-year period of validity referred to in paragraph 1. The application for re-examination shall demonstrate that the exceptional circumstances related to animal health or public health remain.
4. When an application for re-examination has been submitted, the marketing authorisation shall remain valid until a decision has been adopted by the competent authority or the Commission, as applicable.
5. The competent authority or the Agency, as applicable, shall assess the application.
On the basis of that assessment, if the benefit-risk balance remains positive, the competent authority or the Commission, as applicable, shall extend the validity of the marketing authorisation for one year.
6. The competent authority or the Commission, as applicable, may at any time grant a marketing authorisation valid for an unlimited period of time in respect of a veterinary medicinal product authorised in accordance with Articles 25 and 26, provided that the marketing authorisation holder submits the missing data on quality, safety or efficacy referred to in Article 25.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
