Registration Guideline of Veterinary Products.
Country
Type of law
Miscellaneous
Date of original text
Date of latest amendment
Abstract
This Registration Guideline was issued by the Director of Pharmaceutical Services under Control of Drugs and Cosmetics Regulations 1984. It serves as the reference guide for registration of pharmaceutical products for animal use. It provides an overview of registration procedure of VMPs.
The Guideline makes provisions for: information relating to administrative requirements and procedures; information on Drug Control Authority (DCA) policies currently applicable; guidelines on the online application process and requirements which will incorporate the ASEAN technical requirements and standards for pharmaceuticals. According to the Controls of Drugs and Cosmetics Regulations 1984, any company that want to manufacture, import or wholesale any registered products need to have a valid Manufacturer’s License, Import License or Wholesale License. Section 13.2 gives the List of License For Registered Products. Certificates are issued for the purpose of exportation of locally manufactured registered products. It endorses that the local manufacturer complies with the current GMP requirements. Appendix 9 gives the allowable maximum residual limits (MRL).
The Guideline makes provisions for: information relating to administrative requirements and procedures; information on Drug Control Authority (DCA) policies currently applicable; guidelines on the online application process and requirements which will incorporate the ASEAN technical requirements and standards for pharmaceuticals. According to the Controls of Drugs and Cosmetics Regulations 1984, any company that want to manufacture, import or wholesale any registered products need to have a valid Manufacturer’s License, Import License or Wholesale License. Section 13.2 gives the List of License For Registered Products. Certificates are issued for the purpose of exportation of locally manufactured registered products. It endorses that the local manufacturer complies with the current GMP requirements. Appendix 9 gives the allowable maximum residual limits (MRL).
Attached files
Web site
Repealed
No
Source language
English
Legislation Amendment
No