Agence Nationale du Médicament et des Produits de Santé (ANMPS) P-OP2-001-FR,P-OP2-001-FR, Rev 000
P-OP2-001-FR, Rev 000 is the official ANMPS identifier for “Contrôle des dispositifs médicaux, des compléments alimentaires, des produits cosmétiques et des objets de puériculture dans le cadre du contrôle technique à l'importation”. P-OP2-001-FR, Rev 000 is the official identifier ANMPS uses for this instrument.
- Instrument
- P-OP2-001-FR,
- Full name
- P-OP2-001-FR, Rev 000
- Category
- Registration
- Authority source
- French
- Readable HTML
- 0 articles · 1 language version
- Published
- 5 June 2025
- Effective
- —
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Contrôle des dispositifs médicaux, des compléments alimentaires, des produits cosmétiques et des objets de puériculture dans le cadre du contrôle technique à l'importation
P-OP2-001-FR, revision 000 of 5 June 2025, by the ANMPS — the procedure for the technical control at importation of medical devices, food supplements, cosmetic products and childcare articles. Two numbered sections: section 1 presents the document (object, entry into force, references, responsibilities and distribution) and section 2 describes the control, separating cosmetics and food supplements (2.1) from medical devices and childcare articles (2.2), and within the device route separating what is subject only to a technical opinion (2.2.1) from what is subject to a systematic analysis (2.2.2), followed by the conditions for applying the procedure (2.3) and the conditions for obtaining an administrative import authorisation (2.4). A 'Pièce Jointe' block carries the attachment the procedure refers to. This is the instrument that decides what happens to a device consignment at the Tunisian border, and it is the counterpart to the customs-side rules the ANMPS note on hyaluronic-acid devices also touches.
P-OP2-001-FR, Rev 000 is the official identifier ANMPS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.