Regulation on pharmacovigilance for veterinary medicinal products.
Country
Type of law
Regulation
Abstract
This Regulation defines the procedures in the pharmacovigilance system for veterinary medicinal products in case of adverse reactions that are not officially classified as serious.
The person responsible for placing on the market of veterinary medicinal products shall ensure that the suspected unexpected adverse reactions, which are not classified as serious but occurring in the Republic of Croatia, shall be notified to the competent authorities of all Member countries (article 2). Article 3 sets out rules regrading the periodic notification, security notices and related data collection deadlines.
The person responsible for placing on the market of veterinary medicinal products shall ensure that the suspected unexpected adverse reactions, which are not classified as serious but occurring in the Republic of Croatia, shall be notified to the competent authorities of all Member countries (article 2). Article 3 sets out rules regrading the periodic notification, security notices and related data collection deadlines.
Attached files
Web site
Date of text
Entry into force notes
This Regulation enters into force on the day of accession of the Republic of Croatia to the European Union.
Repealed
No
Publication reference
Official Gazette of the Republic of Croatia 79/2009
Source language
English
Legislation Amendment
No
Original title
Pravilnik o farmakovigilanciji za veterinarsko-medicinske proizvode.
Implements