Injectable veterinary medicinal products containing vitamin A for use in food producing species
Table of contents
Overview
On 12 May 2021, the European Medicines Agency (the Agency) completed a review of the safety of injectable veterinary medicines containing vitamin A for use in food producing species. The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that regulatory measures and risk mitigation measures should be taken to assure consumer and user safety, including the amendment of withdrawal periods for milk, meat and offal for food producing species. The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered so that its meat or other animal derived products may be used for human consumption.
Key facts
| Approved name |
Injectable veterinary medicinal products containing vitamin A for use in food producing species
|
| International non-proprietary name (INN) or common name |
Vitamin A (retinol and its esters)
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/141
|
| Type |
Article 35
Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment. |
| Authorisation model |
Nationally authorised product(s)
|
| Opinion date |
12/05/2021
|
| EC decision date |
18/08/2021
|
All documents
-
List item
Injectable veterinary medicinal products containing vitamin A for use in food producing species Article-35 referral - Questions and answers on the review of injectable veterinary medicines containing vitamin A for use in food producing species (PDF/111.54 KB)
First published: 27/09/2021
EMA/279146/2021 -
-
List item
Injectable veterinary medicinal products containing vitamin A for use in food producing species Article-35 referral - Annex I, II, III, IV (PDF/595.78 KB)
First published: 27/09/2021 -
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of CVMP
- Divergent positions – divergent positions of the CVMP members (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)