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République du Mali Décret

Décret n°04-557/P-RM du 01 décembre 2004

Produits du domaine pharmaceutique — définitions et contrôle d’importation des dispositifs médicaux et réactifs (extraits)
MaliPrésident de la République du MaliGeneralCurrentness under review
Document status

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

What this code is

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.

Instrument
Décret
Full name
Décret n°04-557/P-RM du 01 décembre 2004
Category
General
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French
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About this regulation

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.