Common use of Reference GMP Clause in Contracts

Reference GMP. (a) Manufacturers will be inspected in accordance with the applicable GMP of the exporting country (see Appendix 1); (b) With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations will inspect in accordance with its own GMP or, in the absence of specific GMP requirements, in accordance with the applicable GMP of the importing country. This will also be the case when the locally applicable GMP are not considered equivalent, in terms of quality assurance of the finished product, to the GMP of the importing Party. Equivalence of GMP requirements for specific products or classes of products (e.g. investigational medicinal products, starting materials) will be determined according to a procedure established by the Joint Committee.

Reference GMP. (a) Manufacturers will shall be inspected in accordance with the applicable GMP of the exporting country (see Appendix 1);. (b) With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations will shall inspect in accordance with its own GMP or, in the absence of specific GMP requirements, in accordance with the applicable GMP of the importing country. This will also be the case when the locally applicable GMP are not considered equivalent, in terms of quality assurance of the finished product, to the GMP of the importing Party. Equivalence of GMP requirements for specific products or classes of products (e.g. investigational medicinal products, starting materials) will shall be determined according to a procedure established by the Joint Committee.