Minutes of Licensing Committee meeting no. 5/2009
The meeting took place on 2 July 2009.
Agenda
Minutes
Participants
Agenda
1. Approval of agenda
2. Approval of minutes of meeting held on 4 June 2009
3. Announcements
4. Conflicts of interest
5. Consultations
6. Applications for assessment
7. Notification of forum
8. Other cases for discussion
9. Case reporting
10. Guidelines
11. Any other business
Minutes
Re item 1: Approval of agenda
The agenda was approved as presented.
Re item 2: Approval of minutes of meeting held on 4 June 2009
The minutes were approved, noting that the Chairman prior to the meeting of 4 June 2009 had received written comments from those Committee members who had sent their apologies.
Re item 3: Announcements
Marianne Orholm announced that she is acting as Head of Department of Medicine & Toxicology as of 1 July 2009.
Re item 4: Conflicts of interest
Mark Ainsworth reported that his spouse is working for the company holding the marketing authorisation for the product transacted under item 6.4.3. The other Committee members assessed this circumstance to disqualify Mark Ainsworth from participating during the transaction of item 6.4.3.
Re item 5: Consultations
5.1
None.
Re item 6: Applications for assessment
6.1 Centralised procedure
6.1.1.
None.
6.2 Decentralised procedure
6.2.1
QP53
The Committee supported the veterinary assessor’s comments in the assessment dated 25 June 2009.
In the assessment, the veterinary assessor has specified that the following should be added to the summary of product characteristics, section 4.10 Overdose: “Overdoses of three times the recommended dose can induce in very rare cases adverse reactions such as: cutaneous emphysema, nervous disorders, eye disorder and erythema”. The Committee recommended to change the wording ”can induce in very rare cases” to ”has shown” since there had only been one report on one animal.
Christian Friis stated that he intended to submit his written comments after the meeting.
6.3 Mutual recognition procedure
6.3.1
None.
6.4 National procedure
6.4.1
QH01
The Committee supported both the biological assessor's comments in the assessment of 29 April 2009 and the veterinary assessor's comments in the assessment of 25 May 2009.
The Committee found the definition of End Points to be problematic.
The Committee agreed with the assessor that the submitted pre-clinical and clinical data were not good enough to demonstrate sufficient clinical efficacy after IM injection of 10 µg.
The Committee also agreed with the assessor's minimum requirements for a new field study, which are:
- A multi-centre, controlled and randomised study design, which at the same time enables the comparison of results between treatment groups which only differ by one variable.
- A sufficient number of animals to make it possible to identify significant differences, if present, between treatment groups - and, in the case of a non-inferiority design, that clinical equivalence can be established, if present.
The Committee disagreed with the assessor that it should be a requirement that the product's clinical efficacy should be demonstrated without the influence of presynchronisation treatment. The Licensing Committee found that clinical efficacy is difficult to demonstrate without synchronisation.
The Committee found that the applicant ought to elaborate upon the definition of End Points.
The Committee found that the use of pre-puberty pigs and castrated male pigs could be accepted to determine the optimal dose (pre-clinical studies) for further testing in a field study, but did not find that it should appear from the summary of product characteristics because it does not add any valuable information.
At the present time, the Committee did therefore not recommend approval of the application to add pigs as a new species.
6.4.2
QJ01
The Committee supported the veterinary assessor’s comments in the assessment dated 18 June 2009. The Committee added that the assessor should ask, in the assessment, why there is no mentioning of sensitivity (threshold value) for the analytical methods applied to both pigs and poultry. At the present time, the Committee could therefore not recommend approval of the application to reduce the withdrawal period for both poultry and pigs.
6.4.3
N05
Mark Ainsworth left the room during the transaction of this item, cf. item 4.
The Committee supported the clinical assessor’s comments in the assessment of June 2009. At the present time, the Committee could therefore not recommend approval of the application to change the dispensing status from NBS to B.
6.4.4
A03
The Committee did not support the clinical assessor’s comments in the assessment dated 17 June 2009. Consequently, the Committee did not at present recommend approval of the application to change the dispensing status from B to HA, nor did it recommend approval of the application to change the indication text from "Spasms in the gastrointestinal tract" to "For the relief of stomach pain and discomfort associated with cramps in the gastrointestinal tract". The Committee thus maintained its previous recommendation of 8 January 2009.
Re item 7: NOTIFICATION OF FORUM
None
Re item 8: Other cases for discussion
8.1
Consultation on change of dispensing status
In connection with the review of the OTC product range on the Committee meeting of 4 December 2008, the Committee recommended that products containing isosorbide mononitrate (ATC code C01DA14) and isosorbide dinitrate (ATC code C01DA08), with the exception of prolonged-release formulations, should change dispensing status from HA (over-the-counter medicine, pharmacy-only) to HF (over-the-counter medicine, sold in non-pharmacy outlets).
The proposal was submitted for consultation afterwards. The Danish Medicines Agency has received replies from the Association of Danish Pharmacies, Danish Regions and the Danish Medical Association, all of which express concern about changing the dispensing status from HA to HF. The Licensing Committee assessed the responses received and chose to maintain its recommendation.
The Chairman announced that after the meeting he would prepare a written statement highlighting the grounds leading to the Committee's recommendation, which will be circulated to the Committee members for commenting before it is sent to the Danish Medicines Agency.
Re item 9: CASE REPORTING
9.1
None.
Re item 10: GUIDELINES
10.1
None.
Re item 11: ANY OTHER BUSINESS
Bjørn Krølner had heard of a case where a citizen had supposedly received Imozop (ATC code N05CF01) instead of Imolope (ATC code A07DA03) by mistake. The case would be forwarded to the Consumer Safety Division at the Danish Medicines Agency.
A case which was placed in the project room on 30 June 2009 was removed the next day because it was discovered that the date for submitting responses was after the next Licensing Committee meeting. The case was put on the agenda of the Committee meeting of 6 August 2009.
Participants
Present from the Licensing Committee:
Bjarne Ørskov Lindhardt
Mark Ainsworth
Christian Friis
Sven Frøkjær
Mogens Sandbjerg Hansen
Steen Werner Hansen
Gorm Jensen
Bjørn Krølner
Steffen Loft
Lars Kristian Munck
Jens Nielsen
Søren Sindrup
Apologies from:
Else Marie Damsgaard
Written comments from:
Else Marie Damsgaard
Present from the Danish Medicines Agency:
Marianne Orholm
Lisa Agerholm Larsen
Nicolaj Donskov Nielsen
Christina Ploug Jebjerg
Maria Bruun
Else Bak-Jensen
Katrine Damkjær Madsen
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