Veterinary medicines - questions and answers
CMD(v) – Veterinary Coordination group on Mutual recognition and Decentralised procedures
What does CMD(v) mean?
CMD(v) means Veterinary Coordination group on Mutual recognition and Decentralised procedures
Has the CMD(v) started its work?
Yes, the CMD began its activities in November 2005. All member states except for Estonia have nominated a member of the coordination group, also referred to as the CMD(v).
The Danish member of the CMD is Asbjørn Brandt, head of the section of veterinary medicine in the Danish Health and Medicines Authority.
Ref. Article 31 of Directive 2004/28/EC.
Does the Danish Health and Medicines Authority believe that the CMD(v) referral procedure will work?
Yes, the Danish Health and Medicines Authority believes that the CMD(v) referral procedure will work.
At the December 2005 meeting two cases were referred to the CMD(v). In the event of continued disagreement, the case is referred to the CVMP.
The CMD(v) follows a standard management procedure (SMP), referred to as Disagreement in procedures – referral to CMD(v).
Ref. Article 32 of Directive 2004/28/EC.
PuAR - Publicly Available Assessment Report
Will a publicly available assessment report – a PuAR – be prepared for veterinary medicinal products?
Yes, the CMD(v) has agreed that for applications made via the decentralised and mutual recognition procedures the report will be prepared by the reference member state and published on the website of Heads of Medicines Agencies (HMA): (http://www.hevra.org/). The website is currently under improvement to become more user friendly and efficient.
The Danish Health and Medicines Authority does not plan to prepare a Danish version of the assessment report.
The Danish Health and Medicines Authority will follow the CMD(v)'s "Best Practice Guide for the Public Assessment Report in the Decentralised and Mutual Recognition Procedures". This means that the applicant will be consulted before the preparation of a final assessment report.
Ref: Best Practice Guide for the Production of Publicly Available Assessment Reports VMRF/029/05-Consultation.
SPC, PL matters
Is the submission of draft summaries of product characteristics, package leaflets and labelling subject to any specific requirements?
For applications that are submitted via the decentralised or mutual recognition procedure, we request applicants to use the English CMDv template for product information, available on the website: http://www.hma.eu/cmdv.html.
For national translations, regardless of procedure type, we request applicants to use the adapted, Danish QRD (Quality Review of Documents) templates, available on the Danish Health and Medicines Authority's website: Click here.
Renewal, variation, new requirements
Are there any new requirements as to renewal?
Yes, there are a number of new documentation requirements for renewal:
- The marketing authorisation holder (MAH) must document to the Danish Health and Medicines Authority that the risk-benefit ratio remains favourable.
- An updated description of the documentation must be submitted, containing any changes submitted to the Danish Health and Medicines Authority since the granting of the marketing authorisation (MA) as well as the most recent periodic safety update report (PSUR).
The new Medicines Act specifies circumstances in which an MA can be suspended, revoked, withdrawn or varied. This may, for instance, be in case of an inadequate environmental risk assessment (ERA).
At the most recent meetings of the CVMP some chapters in Guideline on Environmental Impact Assessment for veterinary medicinal products were revised. The document will be published at EMEA's website with a six-month consultation period.
Can variations be submitted while a renewal of an MA is being considered?
No, variations cannot be submitted while a renewal of an MA is being considered.
Nevertheless, variations relating to urgent safety restrictions can be considered any time.
Please note that Denmark proposed the following tightening at a meeting of the CMD(v) in December 2005:
"We suggest that a common agreement is reached, stating that the RMS in cooperation with the MAH must ensure that all major differences between MA in all concerned MS are removed by updating the dossiers with appropriate variation procedures before processing the MRP renewal application."
Executive Order on prescriptions
Does the new Executive Order on prescriptions (which came into force in November 2005) comprise any new veterinary aspects?
Yes, there is a new dispensing group, "premix".
This has given rise to harmonisation of the SPC texts for premix based, among other things, on Directive 90/167/EEC, from which it appears that the pharmaceutical form premix may be used for the manufacture of medicated feedingstuffs at an approved feeding mill only.
- Item 3: "Pharmaceutical form", "Premix for medicated feeding stuffs".
- Item 5.8: "Dosage" that mixing instructions, if any, are aimed only at a feeding mill approved for the manufacture of medicated feedingstuffs.
- Item 9: "Dispensing group = premix".
Medicinal products for horses
The availability of medicinal products for horses has been a problem – any news?
Yes, a new species has been "invented", the "microchipped horse". This means that for the rest of its life the horse is excluded as an animal for human consumption.
Ref. Article 6 (1), (2) and (3) of Directive 2004/28/EC.
Medicinal products for this "species" may be approved without the existence or establishment of an MRL ("MRL" stands for maximum residue limit) in animal tissue/foodstuffs (except for substances mentioned in Annex IV to Council Regulation (EEC) No. 2377/90, e.g. chloramphenicol).
If there is no approved medicinal product, a compassionate-use permit may be applied for.
A list is being prepared of essential substances (medicinal products) for horses, according to which horses may be treated provided that a general six-month withdrawal period is fixed, without the horse having to be excluded from the food chain (microchipped), Article 10(3) of Directive 2004/28/EC.
There is a new possibility under the cascade provisions: Medicinal products approved in another EU country may be ordered, but for such medicinal products a compassionate-use permit must also be applied for.
Microchipping may be omitted provided that an MRL exists for another animal for human consumption. Please note that the withdrawal period (in respect of slaughter) will always be minimum 28 days.
Where can you find information relating to the documentation requirements for applications for an MA for a VMP (national, MRP, DCP, CP)?
Information relating to documentation requirements, the so-called Notice to Applicants (NtA) is available at the website of the European Commission: http://pharmacos.eudra.org/.
Guidance documents, Best Practice Guides and certain SOPs relating to procedures, quality, safety and efficacy studies are available at EMEA's website www.emea.eu.int and HEVRA's website www.hevra.org.
Examples of guidance documents are given below:
- Best Practice Guide for handling Renewals in the Mutual Recognition Procedure VMRF/055/01
- Management of Drug Master File (DMF) in the Mutual Recognition Procedure VMRF/060/97
- Repeat Use of the Mutual Recognition Procedure (Rev. 9) VMRF/053/98
- Response Report Mutual Recognition VMRF/090/98
- Procedure for automatic validation of mutual recognition procedures (Rev. 2) VMRF/171/98
- Parallel Applications VMRF/038/99 Proposal for Improvement of Transparency in MRP VMRF/079/99
- Contact points (rev. 19) VMRF/032/01
- Best Practice Guide for Mutual Recognition Procedure VMRF/033/03
- Document management : Standardisation of e-mail headings during MRP VMRF/034/03
- Best Practice Guide for the processing of Type IB variations – AdoptedVMRF/117/03
- Best Practice Guide for the processing of Type II variations – AdoptedVMRF/118/03
- Best Practice Guide for the processing of Type IA variations – AdoptedVMRF/116/03
- Questions and answers relating to the implementation of Directive 2001/82/EC as amended by Directive 2004/28/EC VMRF/456/05
- Best Practice Guide for the Production of Publicly Available Assessment Reports VMRF/029/05-Consultation
- Best Practice Guide for Veterinary Decentralised Procedure VMRF/137/05-Consultation