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Order amending and supplementing the Order No. 69 of 2006 on the requirements for good manufacturing practice in the production of veterinary medicinal products and active substances.

País/Territorio
Bulgaria
Tipo de documento
Reglamento
Fecha
2024
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Medicamentos Sanidad animal Cumplimiento/aplicación Procesamiento/manipulación Inspección Comercio internacional Monitoreo
Área geográphica
Mar Negro, Europa Oriental, Europa, Europa y Central Asia, Países de la Unión Europea
Entry into force notes
This text entered into force on the day of its publication in the Official Gazette (published on 1 March 2024), with the exception of the amendments article 2, item 8.123 of section I "Manufacturing of sterile veterinary medicinal products", chapter three "Additional requirements for the production of various categories veterinary medicinal products", which shall enter into force on 25 August 2024.
Resumen

This Order amends various provisions part of the Order No. 69 of 2006 on the requirements for good manufacturing practice in the production of veterinary medicinal products and active substances (originally published in the Official Gazette of the Republic of Bulgaria 49/2006, and already amended in Gazettes 6 and 85 year 2010, 66/2011, 91/2014, 32/2017, 48/2019 and 104/2023). Changes are concerning several technical issues, definitions and partial meaning of general terms, water systems, barrier technologies, completion of production of sterile products, environment and process monitoring among several other technological and procedural rules.

Texto completo
Búlgaro
Página web
dv.parliament.bg

Referencias - Legislación

Enmienda

Regulation No. 69 of 2006 on the requirements for good manufacturing practice in the production of veterinary medicinal products and active substances.

Legislación | Bulgaria | 2006 (2014)

Palabra clave: Medicamentos, Sanidad animal, Cumplimiento/aplicación, Procesamiento/manipulación, Inspección, Comercio internacional, Monitoreo

Fuente: FAO, FAOLEX