![]() ![]() Member States shall work to register all pharmaceutical preparations centrally in the GCC countries so that they can be transferred between the member states without technical procedures at the intra-borders. (1) (A) Except as provided in paragraph (2) and section 384 of this title, no drug subject to section 353 (b) of this title or composed wholly or partly of insulin which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug. FDA and the Department of Health and Human Services have provided two pathways to allow importation of certain prescription drugs that were originally intended for foreign markets. Guidelines for the import and export of drug and precursor reference standards for use by national drug testing laboratories. ![]() ![]() Procedures for clearance of pharmaceutical preparations that are not centrally registered within the framework of the Council shall be taken at the intra-borders of the Member States, provided that they are not prohibited from importing them at the first point of entry.The procedure for granting such import and export authorisations is. New insulin and antibiotic drug products may be exported for investigational use in accordance with section 801(e)(1) of the act. Pharmaceutical preparations registered centrally within the framework of the Council are transferred between Member States without the need to take technical measures at the intra-borders. In accordance with Section 11 sub-section 1 of the German Narcotic Drugs Act ('Betäubungsmittelgesetz', ), an authorisation from the is necessary for each import and export of narcotic drugs, in addition to the licence required pursuant to Section 3. I2ES is a new online platform developed by INCB with the support of UNODC to facilitate and speed up the process of issuing import and export authorizations for narcotic drugs and psychotropic substances by competent national authorities (CNAs) of importing and exporting countries in compliance with the international drug control treaties.The Code of Principles of Good Distribution and Storage Practice for Gulf pharmaceuticals and the mechanism for clearing medicines and pharmaceutical preparations through the one port in the GCC countries that have been approved by the Gulf Central Committee for Drug Registration are sufficient to release medicines at the first entry points in the GCC countries, as attached. ![]()
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