of June 13, 2024 No. 145
About introduction of amendments to the Law on medicines of veterinary appointment No. 119/2018
The Parliament adopts this organic law.
Single Article. – In the Law on medicines of veterinary appointment No. 119/2018 (Official monitor of the Republic of Moldova, 2018, Art. No. 309-320, 468), with subsequent changes, to make the following changes:
1. Add the law with Article 8-1 of the following content:
"Article 8-1. The simplified procedure of registration of the medicines of veterinary appointment permitted by the centralized procedure by the European agency of medicines
(1) In departure from parts (1), (3) – (13) Article 8 and Article 9 for registration of medicine of the veterinary appointment permitted by the centralized procedure by the European agency of medicines, the applicant submits to the Agency the application for issue of the registration certificate accompanied with the short description of characteristics of means of veterinary appointment published by the European agency of medicines, sample of the label and leaf insert of medicine of veterinary appointment according to Articles 21 and 22, translated into Romanian.
(2) For each pharmaceutical form and different concentration of medicine of the veterinary appointment provided under one trade name the separate application for registration is submitted.
(3) the Proof of payment for registration of medicine of the veterinary appointment permitted by the centralized procedure by the European agency of medicines, in the amount of, established according to the Law on regulation of business activity by permission No. 160/2011, is submitted together with the statement for registration.
(4) In departure from part (3) Article 5 the procedure of issue of the registration certificate of medicine of the veterinary appointment permitted by the European agency of medicines is held within 30 calendar days from the date of filing of application about registration.
(5) In departure from part (4) Articles 5, Articles 8 and 9, parts (1) and (2) the article 13 Agency estimates filed the statement and documents according to part (1), checking reliability and compliance to the provided information.
Full text is available with an active Subscribtion after logging in.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
Search in text CTRL-F
If you are guest on our site, you will work in Demo mode. In Demo mode you can see only first page of each document.
With full access you can
Database include more 65000 documents. You can find needed documents using search system.
For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system
If you cannot find the required document, or you do not know where to begin, go to Help section.
In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.
You also may open the section Frequently asked questions.
This section provides answers to questions set by users.