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Law on veterinary medical products.

Country
North Macedonia
Type of law
Legislation
Source
FAO , FAOLEX
Abstract
This Law regulates the conditions and procedures (including inspection provisions, administrative issues) for approval of marketing, manufacture, import, possession, sale, use and control/inspection of animal medicinal products (including the veterinary-medical instruments and devices for use in veterinary medicine, narcotic drugs, psychotropic substances and precursors needed to produce veterinary medicinal products) on the territory of the Republic of Macedonia.
The Law is divided into VII Chapters and 74 articles including offences and penalties.
Attached files
http://faolex.fao.org/docs/pdf/mac150924.pdf
Web site
http://www.fva.gov.mk
Date of text
Entry into force notes
This Law enters into force eight days after its publication in the Official Gazette.
Repealed
No
Source language

English

Legislation Amendment
No
Original title
Закон за ветеринарно медицински препарат.
Amended by
Law amending the Law on veterinary medical products.
Law amending the Law on veterinary medical products.
Law amending the Law on veterinary medical products.
Law amending the Law on veterinary medical products.
Implemented by
Regulation on the conditions for wholesalers dealing with veterinary medicinal products, as well as on the manner of work.
Regulation on the conditions to be met by veterinary pharmacies, as well as on the manner of their work.
Regulation on data that should be included on the outer packaging and on information and instructions for the use of the veterinary medicinal products.
Regulation on the list of wholesalers and veterinary pharmacies.
Regulation on the list of approved veterinary medicinal products (marketing authorization).
Regulation on the list of pharmacological substances approved for use in veterinary medicine.
Regulation on the conditions in terms of facilities, equipment and personnel to be met by manufacturers of veterinary medicinal products, the form and content of the application and documentation for approval (manufacturing veterinary medicinal products).
Regulation on the conditions in terms of facilities, equipment and personnel to be met by importers of veterinary medicinal products.
Regulation on the form and content of the request for issuance of authorization for placing of veterinary medicinal product, as well as general and special requirements to be met by veterinary medicinal product intended for marketing.
Regulation on requirements to meet the doctor of veterinary medicine as holder of activity in manufacture of veterinary medicinal products.
Regulation on the performance of official controls on veterinary medicinal products.
Regulation on the list of pharmacological substances approved for use in veterinary medicine.
Regulation on the approval and importation of veterinary medicinal products.
Regulation on the form and content, manner of reporting on serious, unexpected and side effects from the use of veterinary medicinal products and the way of monitoring, collection and recording of data.
Regulation on the information to be included in the report for evaluation of veterinary medicinal products.
Regulation on veterinary medicinal products which are temporarily placed on the market.
Regulation on the manner of distribution of veterinary medicinal products in certain categories and on the manner of prescribing and issuance of veterinary medicinal products.
Regulation on the form and content of the application (non-issuance of the approval) for the production of veterinary medicinal products.
Regulation on the form and content of the application (non-issuance of the approval) for the trading and wholesale with veterinary medicinal products.
Regulation on the form and content of the application (non-issuance of the approval) for the marketing permit for veterinary medicinal products.
Regulation on data that should be included on the outer packaging and the information that should contain the instructions for the veterinary medicinal product.
Regulation on the renewal of the marketing authorization for veterinary medicinal products.
Regulation on the format and contents of the form of request for issuing the approval for putting on the market of veterinary medicinal product, as well as general and special conditions that should be fulfilled by vet-med preparations issued on the market.
Regulation on the transfer of marketing authorization (veterinary medicinal product), the content of documents and other necessary data.
Regulation on good distribution practices (veterinary drugs).
Regulation on the ban of manufacture, import, possession, sale, supply and/or use of certain veterinary medicinal products.
Regulation on detailed conditions regarding the manner of operation, space, equipment and staff to be met by veterinary pharmacies.
Regulation on detailed conditions regarding the space, equipment and staff to be met by legal entities performing wholesale of veterinary medicinal products.
Regulation on the principles and guidelines for good manufacturing practice for veterinary medicinal products.