Reference GMP. (a) Manufacturers will be inspected against the applicable GMP of the exporting Party (see Section I).
(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 against its own GMP or, in the absence of specific GMP requirements, against the applicable GMP of the importing Party. 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 Sectoral Group.
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. 5.3.1 For the avoidance of doubt, with respect to medicinal products covered by the mandatory GMP requirements of the importing Party but not the exporting one, GMP inspections by the Inspection Service of the exporting Party shall be in relation to the mandatory GMP requirements of the importing Party. This shall also be the case when the mandatory GMP requirements of both Parties are not regarded as equivalent in accordance with Article 2.3.
5.3.2 Equivalence of GMP requirements for specific products or classes of products shall be determined according to a procedure established by the Parties.
Reference GMP. (a) Manufa cturers shall be inspected in a cc ord ance with the applic able GMP of the exporting c ountry (see Appendix 1).
(b) With respect to medicinal products c overed by the pharma c eutic al legislation of the importing Party but not the exporting one, the loc ally c ompetent inspection servic e willing to c arry out an inspection of the relevant manufa cturing operations shall inspect in a c c ord anc e with its own GMP or, in the absence of specific GMP requirements, in a cc ord ance with the applic able GMP of the importing c ountry. This will also be the c ase when the loc ally applic able GMP are not c onsidered equivalent, in terms of quality assuran c e of the finished product, to the GMP of the importing Party. Equivalence of GMP requirements for specific products or classes of products (e.g. investig ational medicinal products, starting materials) shall be determined a xx xxxxxx to a pro cedure established by the Joint Committee.
Reference GMP. (a) Manufacturers will be inspected against the applicable GMP of the exporting Party (see Section I).
