ABREMA OrdonnanceOrdonnance ministérielle n° 630/991 du 9 août 2023
Ordonnance ministérielle n° 630/991 du 9 août 2023 is the official ABREMA identifier for “Révision des modes et conditions d’homologation des médicaments à usage humain et autres intrants pharmaceutiques au Burundi”. Ordonnance ministérielle n° 630/991 du 9 août 2023 is the official identifier ABREMA uses for this instrument.
- Instrument
- Ordonnance
- Full name
- Ordonnance ministérielle n° 630/991 du 9 août 2023
- Category
- Registration
- Source publication
- French
- Readable HTML
- 1 language version
- Published
- —
- Effective
- 2023-08-09
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Révision des modes et conditions d’homologation des médicaments à usage humain et autres intrants pharmaceutiques au Burundi
Complete 16-page signed replacement expression revising the 2 August 2013 homologation ordinance, with all 39 articles. The defined pharmaceutical-input scope includes articles used for diagnosis, screening, surgery and health protection. Retains registration, reliance, renewal, written variation applications (article 19), retention, suspension and appeals; medicine-specific CTD, labelling and emergency provisions are preserved in context. Articles 9, 11, 19 and 34 refer to separate implementing directives, inspection rules, forms and procedures that must be checked before treating this ordinance as a complete device dossier or change checklist. Article 39 commences it on signature, 9 August 2023; the expired twelve-month transitional submission window is not a current extension.
Ordonnance ministérielle n° 630/991 du 9 août 2023 is the official identifier ABREMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.