By signing a quality technical/technical agreement, both parties develop a common concept of quality. Although it is possible to use contract models, individual specificities must be given due consideration. The EU has adopted MRIs with Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States. All of these agreements concern medicines for human and veterinary use; However, the detailed volume of the product varies. For more details, see: The old Mutual Recognition Agreement (MRA) came into force on May 29, 2004. It allowed regulators to rely on inspections of good manufacturing practices (GMPs) in the affected areas, not to test batches of medicines entering Japan from EU countries and, conversely, to exchange information on inspections and quality defects. The contractor is responsible for outsourced activities and a technical agreement ensures that the contractor respects the principles of GDP. It is important to ensure that the two agreements are linked to each other and to ensure that anomalies between the two documents are avoided, as this could be a challenge in the event of a dispute. CEFIC – Active Pharmaceutical Ingredientsss Committee (APIC), Av. Van Nieuwenhuyse 4 / Box 2, B – 1160 Brussels, Tel. `32 (0)2 676 72 11, www.cefic.org Save my name, email and website in this browser for the next time I pronxed it.
. The following directive can be sorted by address in the “Source/Publisher” category. In cases where you can order on the Internet, we have set up a hyperlink. Any activity covered by the outsourced gdp guide should be properly defined, agreed and controlled to avoid any misunderstandings that could affect the integrity of the product. There must be a written contract between the contractor and the contractor, in which the obligations of each party are clearly defined. When a wholesaler wishes to outsource activities to outside companies, it is appropriate to comply with the requirements of the November 5, 2013 guidelines on good distribution practices for medicinal products for human use (2013/C 343/01), which mention contracts in several chapters. In addition, Section 4.2 (Documentation) contracts should be readily available/accessible in documentation (all written procedures, instructions, contracts, registrations and data on paper or electronic form). This important agreement, which updates the 1998 Mutual Recognition Agreement, reinforces the dependence on know-how and mutual inspection resources. The mutual benefits to the EU authorities and the FDA are: technical agreements on GDP are usually drafted by an expert in gdp principles and trade agreements are drafted by the company`s legal department. By signing a quality technical/technical agreement, both parties develop a common approach to quality.
Although it is possible to use contractual models, individual specificities must be given due consideration. Are your technical agreements on GDP compatible with trade agreements? If you don`t, you`re in serious danger to argue. For example, a technical agreement on GDP between a WDA (H) holder and a contract warehouse may contain the following details: the clauses contained in a technical agreement on gdp principles depend on the outsourcing of the activity. If you need help developing a strong technical agreement on GDP, please contact Pharma Experts. Many transport services for the distribution and supply of medicines are provided by external logistics service providers and other activities in the GDP environment are often outsourced. In this context, the question arises when a technical and qualitative agreement will be signed, what regulatory requirements apply and what aspects should be addressed in such an agreement. The written contract mentioned in the clause is generally referred to as a technical or quality contract and describes the responsibilities of both parties, i.e.: