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Regulatory Rules for Veterinary Medicinal Products, Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 107, 2004.

Pays/Territoire
Japon
Type du document
Règlement
Date
2004 (2017)
Source
FAO, FAOLEX
Sujet
Bétail, Pêche
Mot clé
Médicaments Maladie des poissons Gestion et conservation des pêches Enregistrement Renforcement des capacités Certification Commerce intérieur Commerce international Santé des animaux Parasites/maladies
Aire géographique
Asie, Asie et Pacifique, Asie Orientale, Pacifique Nord, Pacifique Nord Occidental
Résumé

These Regulatory Rules, consisting of 214 articles, establish all matters related to Marketing Business and Manufacturing Industry of Medicinal products and Quasi-drug. Applications for license under the stipulations in the Act, Article 12, Paragraph 1 shall be made by submitting an application form prescribed in Appended Form No. 1 with specific documents listed in the items to the Minister of Agriculture, Forestry and Fisheries. The format of the certificate of license stipulated in the Act Enforcement Ordinance on securing quality, efficacy and safety of products including pharmaceuticals and medical devices. Marketing authorization holders of medicinal products (excluding in vitro diagnostic) or quasi-drug shall display the certificate of license issued as stipulated in the Ordinance. It also regulates antimicrobial substance preparations as medical products that contain antibiotics.

Texte intégral
Japonais/Anglais
Site web
www.maff.go.jp

Références - Législation

Implemente

Law No. 145 on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices.

Législation | Japon | 1960 (2015)

Mot clé: Pesticides, Enregistrement, Résidus, Toxicité/empoisonnement, Infractions/sanctions, Santé publique, Commerce intérieur, Commerce international, Contrôle de qualité alimentaire/innocuité des produits alimentaires, Développement agricole, Médicaments, Santé des animaux, Agents de lutte biologique, Pollution du sol/qualité

Source: FAO, FAOLEX

Implementé par

Ministerial Ordinance Concerning Manufacturing Control and Quality Control of Veterinary Medicinal Products No. 18, 1994.

Législation | Japon | 1994 (2014)

Mot clé: Monitorage, Médicaments, Maladie des poissons, Gestion et conservation des pêches, Commerce intérieur, Commerce international, Santé des animaux, Parasites/maladies

Source: FAO, FAOLEX