Billy Timmins
Ceist:109 Mr. Timmins asked the Minister for Agriculture and Food the medicines he has re-classified since 1 January 2003, leading to restricted sales outlets; and if he will make a statement on the matter. [22607/03]
Written Answers. - Animal Medicines.
Under current legislation, competence for licensing animal medicinal products is divided between my Department and the Irish Medicines Board. Hence, this reply relates only to veterinary vaccines where competence rests with my Department. Since licences in respect of animal vaccines which had been granted under the Therapeutic Substances Act 1932 no longer met current scientific or EU legislative requirements, it was necessary to review all such licences on an individual basis. Under the review, which has been ongoing since 1999, the Irish Medicines Board carried out the detailed examination of application dossiers submitted by sponsoring companies. On this basis, the board makes a recommendation to my Department as competent authority which makes a final decision on the grant or otherwise of a licence and on the conditions, including route of supply, accompanying such licence.
In terms of designating routes of supply for individual vaccines, my Department does not have a general approach which would as a matter of policy necessarily exclude any of the categories provided for under the Animal Remedies Regulations 1996. Rather, the decision is taken on the basis of the characteristics of each individual product taking account of the relevant recommendation of the Irish Medicines Board and the objective criteria laid down in regulation 13 of the Animal Remedies Regulations 1996.
Since the licences which were in place under the aforementioned Therapeutic Substances Act did not specify a mandatory route of supply, re-classification in this regard does not arise. However, the following is a list of vaccines in respect of which licences have been issued following review, and which now specify a mandatory route of supply, by my Department since 1 January 2003.
|
Date Licence Issued |
VPA |
Company Name |
Product Name |
Route of Sale |
|
15/01/2003 |
10277/062/01 |
Schering Plough Limited |
Leptavoid-H |
POM(E)1 |
|
19/02/2003 |
10996/136/01 |
Intervet Ireland Limited |
Nobilis IB Ma 5 |
POM(E)1 |
|
03/03/2003 |
10861/057/01 |
Fort Dodge Animal Health |
Poulvac Past M |
POM(E)1 |
|
07/03/2003 |
10019/70/01 |
Pfizer (Ireland) Ltd |
Spirovac |
POM(E)1 |
|
21/03/2003 |
10996/140/1 |
Intervet Ireland Limited |
Colisorb |
POM(E)1 |
|
21/03/2003 |
10996/149/1 |
Intervet Ireland Limited |
Ovivac P Plus |
POM(E)1 |
|
21/03/2003 |
10996/146/1 |
Intervet Ireland Limited |
Heptavac P Plus |
POM(E)1 |
|
21/03/2003 |
10996/141/1 |
Intervet Ireland Limited |
Porcovac Plus |
POM(E)1 |
|
04/04/2003 |
10996/133/1 |
Intervet Ireland Limited |
Nobilis Gumboro D78 Live |
POM(E)1 |
|
09/04/2003 |
10996/150/1 |
Intervet Ireland Limited |
Tetanus Antitoxin Behring |
LM3 |
|
01/05/2003 |
10019/67/1 |
Pfizer (Ireland) Ltd |
Rispoval RS |
POM2 |
|
02/05/2003 |
10846/4/2 |
Laboratorios Hipra S.A. |
MYPRAVAC SUIS |
POM(E)1 |
|
02/05/2003 |
10857/44/1 |
Merial Animal Health Limited |
Geskypur |
POM2 |
|
06/06/2003 |
10019/66/1 |
Pfizer (Ireland) Ltd |
Imuresp RP |
POM2 |
|
06/06/2003 |
10977/7/1 |
Lohmann Animal Health GmbH & Co. KG |
TAD Salmonella Vac E |
POM2 |
|
06/06/2003 |
10996/78/1 |
Intervet Ireland Limited |
Bovilis IBR |
POM2 |
|
06/06/2003 |
10996/128/1 |
Intervet Ireland Limited |
Porcilis PRRS IM |
POM2 |
|
06/06/2003 |
10996/128/2 |
Intervet Ireland Limited |
Porcilis PRRS IDAL |
POM2 |
|
06/06/2003 |
10846/3/1 |
Laboratorios Hipra S.A. |
Hiprabovis-4 |
POM2 |
|
06/06/2003 |
10007/37/1 |
Boehringer Ingelheim |
Ingelvac PRRS KV |
POM2 |
|
06/06/2003 |
10857/48/1 |
Merial Animal Health Limited |
Progressis |
POM2 |
|
13/06/2003 |
10996/78/1 |
Intervet Ireland Limited |
Bovilis IBR + P13 |
POM2 |
|
23/06/2003 |
10857/51/1 |
Merial Animal Health Limited |
Gallivac IB88 |
POM(E)1 |
|
29/07/2003 |
10996/175/1 |
Intervet Ireland Limited |
Norvax Compact 4 |
POM(E)1 |
|
06/08/2003 |
10996/86/1 |
Intervet Ireland Limited |
Nobilis Rismavac + CA126 |
POM2 |
|
06/08/2003 |
10857/32/1 |
Merial Animal Health Limited |
Trivacton 6 |
POM(E)1 |
|
06/08/2003 |
10857/33/1 |
Merial Animal Health Limited |
Imocolibov |
POM(E)1 |
|
13/08/2003 |
10857/29/01 |
Merial Animal Health Limited |
Pastobov |
POM(E)1 |
|
18/08/2003 |
10996/80/1 |
Intervet Ireland Limited |
Toxovax |
POM2 |
|
27/08/2003 |
10996/176/1 |
Intervet Ireland Limited |
Nobivac Pi |
POM2 |
|
27/08/2003 |
10996/145/1 |
Intervet Ireland Limited |
Heptavac |
POM(E)1 |
|
28/08/2003 |
10857/34/1 |
Merial Animal Health Limited |
Miloxan |
POM(E)1 |
|
15/09/2003 |
10861/56/1 |
Fort Dodge Animal Health |
Poulvac Marek CVI |
POM(E)1 |
|
03/10/2003 |
10996/177/1 |
Intervet Ltd |
Nobivac Solvent |
LM3 |
1. POM(E) (Prescription Only Exempt) refers to products which may be sold from a pharmacy by a pharmacist or by a veterinarian in respect of animals under his/her care.
2. POM (Prescription Only) refers to products which may be sold from a pharmacy on the prescription of a veterinarian, or sold by a veterinarian in respect of animals under his care.
3. LM (Licensed Merchant) refers to products which may be sold from an outlet licensed under the Animal Remedies Regulations, 1996, or from a pharmacy or by a vet for animals under his/her care.