Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
Table of contents
Overview
New measures to reduce risks from exposure to the excipient N-methyl pyrrolidone in veterinary medicines
On 8 December 2022, EMA’s veterinary medicines committee, CVMP, recommended new measures to reduce the risks from exposure to N-methyl pyrrolidone (NMP) for women who may handle veterinary medicines containing this excipient and animals that are given these medicines. The recommendations addressed inconsistencies in the product information of veterinary medicines containing NMP, which are marketed in many European Union (EU) Member States.
NMP is an excipient (ingredient of a medicine other than the active substance) used in some veterinary medicines that is classified as a teratogen (a substance that can cause birth defects following exposure during pregnancy) in laboratory animals. There is therefore the possibility that NMP could cause birth defects in the children of women who handle or come into contact with NMP-containing medicines during their pregnancy, and in the offspring of animals given these medicines.
The CVMP recommended that veterinary medicines that expose the user to amounts of NMP above a certain threshold should not be given to animals by pregnant women or by women who may be pregnant. Furthermore, women who are able to have children should exercise caution when using these medicines. This includes wearing personal protective equipment such as gloves, particularly for pour-on and spot-on products, shampoos, sprays and concentrates for oral solutions.
The Committee also recommended that in the absence of studies demonstrating the safe use of veterinary medicines containing NMP in the target animal species during pregnancy, lactation or lay, NMP-containing veterinary medicines should only be given to animals that are pregnant, lactating, in lay or intended for breeding after assessment of the benefits and risks by the treating veterinarian. To assist veterinarians in their decision-making, the product information must specify the precise quantity of NMP contained in these veterinary medicines.
The recommendations follow a review by the CVMP of all available data and the evaluation of user risk assessments for veterinary medicines containing NMP to assess the risk for users with each pharmaceutical form of these medicines. The product information of these veterinary medicines is being updated with the new recommendations and warnings.
The CVMP recommendations were sent to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 28 March 2023.
Key facts
| Approved name |
Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
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| Associated names |
|
| Current status |
European Commission final decision
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| Reference number |
EMEA/V/A/146
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| Type | |
| Authorisation model |
Centrally and nationally authorised products (mixed)
|
| Opinion date |
08/12/2022
|
| EC decision date |
28/03/2023
|
All documents
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N-methyl-pyrrolidone - Article-82 referral - New measures to reduce risks from exposure to the excipient N-methyl pyrrolidone in veterinary medicines (PDF/138.49 KB)
First published: 18/05/2022
Last updated: 14/04/2023
EMA/131536/2023 -
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N-methyl-pyrrolidone - Article-82 referral - CVMP list of questions to be addressed by the stakeholders (PDF/117.12 KB)
First published: 18/05/2022
EMA/CVMP/232862/2022 -
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N-methyl-pyrrolidone - Article-82 referral - Annex A (PDF/60.72 KB)
First published: 18/05/2022
Last updated: 14/09/2022 -
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N-methyl-pyrrolidone - Article-82 referral - Notification (PDF/250.14 KB)
First published: 18/05/2022 -
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N-methyl-pyrrolidone - Article-82 referral - Timetable for procedure under Article 82 of Regulation (EU) 2019/6 (PDF/131.85 KB)
First published: 18/05/2022
EMA/CVMP/154238/2022 -
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N-methyl-pyrrolidone - Article-82 referral - Stakeholder submission form (PDF/1.29 MB)
First published: 18/05/2022
Consultation dates: 18/05/2022 to 13/09/2022 -
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N-methyl-pyrrolidone - Article-82 referral - Annexes I, II and III (PDF/1.51 MB)
First published: 14/04/2023 -
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)