26 February 2018 EMA/51903/2018 Veterinary Medicines Division
Monthly report on application procedures, guidelines and related documents for veterinary medicines January 2018
This report, which is updated every month, provides current information related to the volume and evaluation of pre- and post-authorisation applications for medicinal products for veterinary use received by the European Medicines Agency (EMA) for the current and previous three years on: •
scientific advice requests;
•
applications for initial evaluations, extensions, variations and renewals concerning marketing authorisations (MAs);
•
applications for initial evaluations, extensions, modifications and extrapolations for maximum residue limits (MRLs);
•
arbitration and referral procedures;
•
requests for classification and re-classifications of products as Minor Use Minor Species (MUMS)/limited market.
In addition, the report includes a summary table of the opinions issued by the Committee for Medicinal Products for Veterinary Use (CVMP) in the current year, as well as a list of adopted guidelines and other public guidance documents. The purpose is only to provide ongoing factual information. Commentaries and analysis are provided in the Agency's annual reports.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
Statistics on pre- and post-authorisation applications for medicinal products for veterinary use Scientific advice requests 2015
2016
2017
2018
Submitted and validated
27
18
17
1
Advice given
29
18
20
2
Scientific advice requests submitted and advice given 35 30
27
29
25 18
20
20
18
17
15 10 5
2
1
0
2015
2016
2017
Submitted
2018
Advice given
Initial evaluation of marketing authorisation applications 2015
2016
2017
2018
Full (submitted)
6
18
12
0
Abridged/generics (submitted)
4
3
5
0
Withdrawals
0
1
1
0
14
11
18
0
1
1
0
0
Positive opinions Negative opinions
Pre-authorisation: submissions of MA applications by type
16
20
0
1
14
3
12
15
5
20 18
25
10
Pre-authorisation: outcome of the evaluation of MA applications
1
10
5
18
8 4
6
18
4
12
Full (submitted)
11
2
6 2015
14
0 2016
2017
2018
2015
Abridged/generics (Submitted)
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
2016
Positive opinions
2017
2018
Negative opinions
Page 2/10
Marketing authorisations 2015
2016
2017
2018
17
7
18
2
Withdrawals
3
1
0
0
Refusal
1
0
0
0
Not renewed
0
1
0
0
2015
2016
2017
2018
Submitted
3
3
5
0
Withdrawals
0
0
0
0
Positive opinions
6
5
2
0
Negative opinions
1
0
0
0
2015
2016
2017
2018
Type-IA variations
196
243
238
8
Type-IB variations
116
126
130
3
Type-II variations
61
41
78
5
5
5
3
0
Granted
Extensions — applications
Variations — applications submitted
Transfers
500
Post-authorisation: submissions of variations and transfers
450 400
5
350
61
300 250
3
5
78
41 126
130
243
238
2016
2017
116
200 150 100
196
50 0
2015 Type IA variations
2018
Type IB variations
Type II variations
Transfers
2015
2016
2017
Submitted
24
13
9
1
Positive opinions
19
14
10
2
0
0
0
0
Renewals — applications
Negative opinions
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
Page 3/10
Establishment of MRLs for new substances 1 — applications 2015
2016
2017
2018
Submitted
4
6
3
0
Withdrawals
1
0
2
0
3 (1)
2
4
0
0
0
0
0
2015
2016
2017
2018
3
1
3
0
Positive opinions
2,3
Negative opinions
Extensions/modifications of MRLs 4 — applications
Submitted
0
1
0
0
2
Positive opinions
2
3
2
0
Negative opinions
0
0
0
0
Withdrawals
Review of opinions/extrapolations of MRLs 5 – requests from Commission or Member States 2015
2016
2017
2018
Submitted
1
0
0
0
Opinion2
3
0
0
0
Substances considered as not falling within the scope of Regulation (EC) No 470/2009 — requests 2015
2016
2017
2018
Submitted
14
4
4
0
Agreed
18
3
2
0
Not agreed
2
0
0
0
Scientific advice recommended
1
1
1
0
MRL-related submissions 25 20 15
14
10 5 0
4
1 3
1 6
4 2015
2016
New applications full Review/extrapolations
4 3 3 2017
2018
Extensions/modifications Out of scope
1
Establishment of MRLs for new substances under article 3 of Regulation (EC) No 470/2009. Including opinions recommending the extension of the expiry date for provisional MRLs or definitive MRLs for substances previously with provisional MRLs. 3 Re-examinations of opinions are indicated in brackets. 4 Extension or modification of MRLs under article 3 of Regulation (EC) No 470/2009. 5 Review of opinions under article 11 of Regulation (EC) No 470/2009 or requests under article 27 of Regulation (EC) No 470/2009. 2
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
MUMS/limited market reclassification with financial incentives
2017
17
MUMS/limited market with financial incentives MUMS/limited market without financial incentives
2016
6
MUMS/limited market reclassification without 6
financial incentives
Not MUMS/limited market 35
Outcome of MUMS/limited market (re-)classification requests
30
1 5
25 20 15
7
3 1 3
2 2
16
10
15
17
5
7
3
2
2017
2018
1
0
2015
2016
MUMS with financial incentives Not MUMS Re-classification without incentives
MUMS without financial incentives Re-classification with incentives
Arbitrations and referrals 2015
2016
2017
2018
7
8
1
0
5
7
7(1)
0
Arbitrations and referrals submitted Opinions 7
Arbitrations and referrals submissions and opinions 9 8 7
8 7
7
6
7
5
5 4 3 2
1
1 0
2015
2016
Referrals submitted
6 7
2017
2018
Opinions and re-examinations
For re-classification the first year available is 2014. Re-examinations of opinions are in brackets.
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
Page 5/10
CVMP opinions in 2018 on medicinal products for veterinary use Positive opinions No opinions have yet been given in 2018.
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
Page 6/10
CVMP opinions in 2018 on establishment of MRLs Positive opinions No opinions have yet been given in 2018.
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
Page 7/10
Arbitrations and referrals in 2018 Ongoing procedures Type of procedure
•
Date
Product
• Clock start
• Product name
• CVMP opinion
• INN
Referral under Article
•
13/07/2016
34 of Directive
•
05/10/2017
2001/82/EC
•
•
(re-examination)
•
Referral under Article
•
13 of Regulation (EC)
•
No. 1234/2008
06/09/2017
•
Girolan and its associated name
•
Apramycin sulfate
•
Seresto and its associated name
Apralan
Foresto •
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
Imidacloprid and flumethrin
Page 8/10
Guidelines and working documents in 2018 CVMP quality No guidelines or working documents have yet been agreed in 2018. CVMP safety Reference number
Document title
Status
EMA/CVMP/SWP/779037/2017
Concept paper for the revision of
Adopted for consultation
the guideline on safety 4 and
January 2018
residue data requirements for pharmaceutical 5 veterinary
(End of consultation 28
medicinal products intended for
February 2018)
minor use or 6 minor species (MUMS)/limited market CVMP efficacy No guidelines or working documents have yet been agreed in 2018. CVMP pharmacovigilance No guidelines or working documents have yet been agreed in 2018. CVMP antimicrobials No guidelines or working documents have yet been agreed in 2018. CVMP immunologicals No guidelines or working documents have yet been agreed in 2018. CVMP environmental risk assessment Reference number
Document title
Status
EMEA/CVMP/ERA/172074/2008
Questions and Answers on the
Adopted January 2018
Rev. 6
implementation of the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH GL6 (Phase I) and GL38 (Phase II)
CVMP novel therapies No guidelines or working documents have yet been agreed in 2018. Replacement, Reduction, Refinement of animal testing (3Rs) No guidelines or working documents have yet been agreed in 2018.
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
Page 9/10
General Reference number
Document title
Status
EMA/CVMP/VICH/517152/2013
VICH GL57: Studies to evaluate
Adopted for consultation
the metabolism and residue kinetics
January 2018
of veterinary drugs in foodproducing species: marker residue
(end of consultation 15 June
depletion studies to establish
2018)
product withdrawal periods in aquatic species
Monthly report on application procedures, guidelines and related documents for veterinary medicines EMA/51903/2018
Monthly report on application procedures guidelines and related ...
Feb 26, 2018 - 2 Including opinions recommending the extension of the expiry date for provisional MRLs or definitive MRLs for substances previously with provisional MRLs. 3 Re-examinations of opinions are indicated in brackets. 4 Extension or modification of MRLs under article 3 of Regulation (EC) No 470/2009.
Apr 12, 2017 - Monthly report on application procedures, guidelines and related ... Commentaries and analysis are provided in ..... data for centrally authorised.
Aug 10, 2017 - Guideline on the plant testing strategy for veterinary medicinal ... allogenic stem cell-based products for veterinary use: specific questions on ...
Feb 13, 2017 - products for use in cattle. Adopted January 2017. CVMP pharmacovigilance. Reference number. Document title. Status. CVMP antimicrobials.
Aug 5, 2016 - documents for veterinary medicines. In addition ... adopted guidelines and other public guidance documents. ..... sign-off by the VICH Steering.
Nov 7, 2016 - related documents for veterinary medicines. October 2016 ..... Guidelines and working documents in 2016 ..... following the sign-off by the.
Jul 3, 2016 - Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of New. Active Substance (NAS) status of.
Jun 12, 2017 - Initial evaluation of marketing authorisation applications .... 1 Establishment of MRLs for new substances under article 3 of Regulation (EC) No ...
Jul 3, 2016 - Monthly report on application procedures, guidelines and related documents for veterinary medicines. In addition, the report includes a ...
Jan 13, 2017 - related documents for veterinary medicines. December ... other public guidance documents. The purpose is only ..... following the sign-off by the.
Jul 10, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the ..... solutions for injection for intramuscular use in ...
Jul 10, 2017 - Send a question via our website www.ema.europa.eu/contact ... This report, which is updated every month, provides current information related ...
Aug 10, 2017 - ... Use (CVMP) in the current year, as well as a list of adopted guidelines and ..... (literature, internet and social media) for veterinary medicinal.
Feb 22, 2017 - An agency of the European Union. Telephone ... Initial Evaluation of Marketing Authorisation Applications (MAA) for ATMP. 2009 ... other documents can be found on the internet at the following location: European Medicines.
Mar 22, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union. Telephone +44 (0)20 3660 6000 ... The guideline, which is a revision of the guideline on genetically modified cells published i
Apr 26, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the ... The Committee for Advanced Therapies (CAT) held its 103rd CAT meeting on 18 â 20 April 2018. The CAT Monthly Report includes statistical
Feb 22, 2017 - methods for cell-based ATMPs. .... other documents can be found on the internet at the following location: European ... Fax: (+44-20) 3660 5520.