Décret n°04-557/P-RM du 01 décembre 2004
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Décret n°04-557/P-RM du 01 décembre 2004 is the official République du Mali identifier for “Produits du domaine pharmaceutique — définitions et contrôle d’importation des dispositifs médicaux et réactifs (extraits)”. Décret n°04-557/P-RM du 01 décembre 2004 is the official identifier République du Mali uses for this instrument.
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- Décret
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- Décret n°04-557/P-RM du 01 décembre 2004
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Produits du domaine pharmaceutique — définitions et contrôle d’importation des dispositifs médicaux et réactifs (extraits)
Selected MD/IVD-related provisions of Décret04-557/P-RM: complete identity/preamble; Article1 and complete Article2 definitions as scope context; Article17 enabling a joint order to identify pharmaceutical-domain products not requiringAMM but subject to import control; Article18 repeal clause; and Article19 execution/publication with all six printed signatories. Article2(e) separately names sterile medicaldevices, conditioned diagnostic/pregnancy reagents and parenteral syringes/needles. Medicine-only AMM validity, fee and variation provisions are not extended to all devices. Known implementing Arrêté05-2203/MS-MEP-SG expressly applies04-557 and its Articles26–32 provide the specific non-AMM import-control mechanism for sterile/nonsterile devices and laboratory reagents; that separate expression is not merged here. This plan publishes selected regions on physical19–22 of a40-page Gazette, not the full pharmacy decree or fullGazette. Printed signing date1December2004 is clear. Containercover prints20Mars2005 whereas runningheaders on19/21 print20Janvier2002; discrepancy retained, no precise publication/effective date assigned. Later amendments and currentness remain unverified.
Décret n°04-557/P-RM du 01 décembre 2004 is the official identifier République du Mali uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.