/ National Agency for Food Safety
Mihail Kogalniceanu Street 63 MD-2009,
mun. Chisinau, Republic of Moldova
Tel / Fax. 022 294 730
e-mail:
web: / Republican Veterinary Diagnostic Center,
Murelor street, MD-2051,
mun. Chisinau, Republic of Moldova,
Tel / Fax. 022 74 23 11
web: /

APPLICATION FOR MARKETING AUTHORISATION OF VETERINARY PHARMACEUTICAL PRODUCTS IN THE REPUBLIC OF MOLDOVA

This application refers to
Primary authorisation
Renewal authorisation
This space is it to be used only by Agency or RVDC employees
______
assigned code date
1. General data
a) Classification
Product type / Select / Fill in the indicated points:
Veterinary medicinal product / for animals of economic interest / 1a-d, 2a-c, 3ab, 4a-e, 5, 6abc, 7a-c, 8a-c, 9ab, 10
for pets / 1a-d, 2a-c, 3ab, 4a-e, 5, 6abc, 7a-c, 8a-c, 9ab, 10
Immunological veterinary medicinal product / 1a-d, 2a, 3a-c, 4a-e, 5, 6abc, 7a-c, 8a-c, 9ab, 10
Active farmacological substance / for animals of economic interest / 1a-d, 2a-c, 3ab, 4a-e, 6a-c, 7abc, 8a-c, 9ab, 10
for pets / 1a-d, 2a-c, 3ab, 4a-d, 6a-c, 7abc, 8a-c, 9ab, 10
desinfectant / 1a-d, 2a, 3a-c, 4a-e, 6ab, 7a-c, 8a-c, 9ab, 10
raticide / 1a-d, 2a, 3a-c, 4a-e, 6ab, 7abc, 8a-c, 9ab, 10
insecticide / 1a-d, 2a, 3a-c, 4a-e, 6ab, 7a-c, 8a-c, 9ab, 10
Premix
(premixture) / medicated / 1a-d, 2a, 3a, 4, 4a-e, 5, 6abc, 7a-c, 8a-c, 9ab, 10
unmedicated / 1a-d, 2a, 3a, 4, 4a-e, 5, 6ab, 8a-c, 10
Feed aditive / 1a-d, 2a, 3a-c, 4a-e, 5, 6ab, 7b, 8a-c, 9ab, 10
b) The application is accompanied by:
Data, documents or materials submitted / Present or missing / Nr. file files
(with figures and letters)
Administrative data
Documentation regarding quality
Documentation regarding safety
Documentation regarding efficacity
Samples of the product / no. of ……... samples
Reference standards, etc.
c) National sanitary-veterinary autorization its beeng issued for
(shall be attached to the registration dossier)
manufacture / import of veterinary pharmaceuticals in the Republic of Moldova
import / distribution of veterinary pharmaceuticals in the Republic of Moldova
d) Language of presentation of the documentation submitted for autorisation
The documentation submitted is presented in the language:
If other than Romanian, Russian or
English, the translation was done by the translation office:
2. Product identification
a) Trade name of the product: ______
b) ATCvet code assigned: ______
Note: fill in as per
c) Pharmacotherapeutic group: ______
3.Composition
a) Name of the active substance(s):______
b) Excipients
______
c) Diluents
______
4.Pharmaceutical form, strength, route of administration, packaging and pack size(s)
Note: use standard terminology - according to the European Pharmacopoeia
a) Pharmaceutical form: ______
b) Active substance(s) ______
c) Strength(s)______
d) Route of administration ______
e) Packaging
primary package / secundary package
Package size
Type of package
Nature and composition of package
5. Target species, dose and waiting period
Animal species / Dose / waiting period, days
Young / Adult
Horse
Bovine
Swine
Leporidae
Chicken
Geese, ducks
Fish
Dogs
Cats
Other______
6. Shelf life, storage conditions andlegal status
a) Shelf life: ______
Shelf life after first opening container: ______
Shelf life after reconstitution or dilution: ______
b) Storage conditions: ______
______
Storage conditions after first openingof container: ______
______
Note: To be completed according to the data in the documentation submitted for autorisation
c) Legal status: Subject to medical prescription Not subject to medical prescription
Note: To be completed according to the legal requirements of the Republic of Moldova
7. Marketing authorization holder/Contact person/Company
a) Marketing authorization holder:
(Company) Name: ______
Address: ______
Country: ______
Telephone: ______
E-mail: ______
Contact person at this address: ______
b) Person/Company authorized for communication between the marketing authorization holder and the National Agency for Food Safety, after authorization procedure in Republic of Moldova.
Note: To be filled in if it differs from the company mentioned in paragraph 7 a)
(attach letter of authorization):
Name: ______
Company Name: ______
Address: ______
Country: ______
Telephone: ______
E-mail: ______
c) Qualified person in Republic of Moldova for Pharmacovigilance:
Name: ______
Company Name: ______
Address: ______
Country: ______
Telephone: ______
E-mail: ______
8. Manufacturer
a) Authorized manufacturer responsible for batch release
Company Name: ______
Address: ______
Country: ______
Telephone: ______
E-mail: ______
Manufacturing Authorization number:______
b) Manufacturer of the active substance
Active substance: ______
Company Name: ______
Address: ______
Country: ______
Telephone: ______
E-mail: ______
c)Company authorized for the payment of authorization fees
Company Name: ______
Address: ______
Country: ______
Telephone: ______
E-mail: ______
9. Marketing authorization in the country of manufacturer or in the country of marketing authorization holder
a) information about authorization
Number of authorization: / Date of authorization: / Shelf life
b) Countries where the medicinal product was authorized
Country: / Number of authorization: / Date of authorization: / Trade name
10. Declaration and signature
The undersigned,
  • assumesthe responsibility on the written information in this application,
  • confirms that all the data indicated in this application correspond to the documentation submitted for the registration of the product requested to be registered,
  • confirms that all existing data relevant for benefit/risk ratio evaluation of the product are presented.
Name/Function / Signature / Date

Approved by the Order of the National Agency for Food Safety no. 114 of 28.02.20181