Gutal
Table of contents
Overview
On 6 May 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Gutal 1000 g/kg premix for medicated feeding stuff for piglets. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Gutal can be granted provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc in the environment, are added to the product information.
Key facts
| Approved name |
Gutal
|
| International non-proprietary name (INN) or common name |
zinc oxide
|
| Class |
-
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/108
|
| Type |
Article 33
Mutual-recognition and decentralised referral: initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure. |
| Opinion date |
06/05/2015
|
| EC decision date |
22/10/2015
|
All documents
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List item
Questions and answers on Gutal 1000 g/kg premix for medicated feeding stuff for piglets (zinc oxide) (PDF/76.29 KB)
First published: 26/11/2015
Last updated: 26/11/2015
EMA/709250/2015 -
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List item
Gutal Article 33(4) referral - Annex I, II, III (PDF/102.53 KB)
First published: 26/11/2015
Last updated: 26/11/2015 -
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List item
Divergent position on a CVMP opinion on an Article 33(4) referral of Directive 2001/82/EC for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (EMEA/V/A/108) (PDF/50.54 KB)
First published: 26/11/2015
Last updated: 26/11/2015
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)