Common use of End of Transitional Period Clause in Contracts

End of Transitional Period. 7.5.1. At the end of the transitional period, the joint sectoral group will proceed to a joint evaluation of the equivalency and capabilities of the compliance programmes of the participating authorities (Appendix 2). 7.5.2. Those determined as not being equivalent to the other Party’s GMP compliance programme will not be listed in Appendix 2 at the end of the transitional period. Proposals to limit the recognition of the equivalence of an authority or exclude it from the Appendix should be based on objective criteria and documented evidence. 7.5.3. Authorities may be placed in Appendix 2 for specific categories of manufacturing processes (e.g. biologicals, radiopharmaceuticals). Excluded authorities (or not included for a given manufacturing process) may apply for re-consideration of their status once the necessary corrective measures have been taken.

Appears in 2 contracts

Sources: Mutual Recognition Agreement, Mutual Recognition Agreement

End of Transitional Period. 7.5.1. At the end of the transitional period, the joint sectoral group Joint Sectoral Group will proceed to a joint evaluation of the equivalency and capabilities of the compliance programmes of the participating authorities (Appendix 2). 7.5.2. Those determined as not being equivalent to the other Party’s GMP compliance programme will not be listed in Appendix 2 at the end of the transitional period. Proposals to limit the recognition of the equivalence of an authority or exclude it from the Appendix should be based on objective criteria and documented evidence. 7.5.3. Authorities may be placed in Appendix 2 for specific categories of manufacturing processes (e.g. biologicals, radiopharmaceuticals). Excluded authorities (or not included for a given manufacturing process) may apply for re-consideration of their status once the necessary corrective measures have been taken.

Appears in 1 contract

Sources: Mutual Recognition Agreement (Mra) on Good Manufacturing Practices (Gmp) Compliance Certification