MRA Flashcards
MRA countries, mhra list of authorised countries for batch testing
Australia
Israel
Japan
Switzerland
United States of America
EU
New Zealand
Canada
The products not included in the scope of these MRA agreements are:
Australia
Advanced Therapy Medicinal Products
Canada
Medicinal products derived from human blood or blood plasma
Advanced Therapy Medicinal Products
Israel
Medicinal gases
Homeopathic products
Medicinal products derived from human blood or blood plasma
Advanced Therapy Medicinal Products
Japan
Medicinal gases
Medicinal products derived from human blood or blood plasma
Advanced Therapy Medicinal Products
New Zealand
Advanced Therapy Medicinal Products
United States of America
Vaccines
Advanced Therapy Medicinal Products
Medicinal products derived from human blood or blood plasma
Where do you find countries and scope of MRA / approved countries for batch testing
MHRA website
MRA countries scope
Australia - Human and Vet, commercial and CT. Excludes ATMP
Canada - Commercial and CT, excludes PAIs and blood products. Excludes ATMP and blood products
Israel - Human and vet, API and intermediates. Excludes ATMP and blood products, medicinal gases and homeopathic products
Japan - API and most human products. Excludes ATMP and blood products and medicinal gases
New Zealand - Human and vet, commercial and CT. Excludes ATMPs
Switzerland - Commercial and CT, Human and vet
United States of America - Excludes ATMP and blood products and vaccines
EU
The general basis of mutual recognition is
Removal of barriers to trade
* Promotion of harmonisation of…
Standards and guidelines for GMP
Application of GMP inspections in the industry
* Fostering good relations between industry and authorities
* Sharing information regarding GMP
* TO PROTECT PATIENTS!
The conditions which should apply to MRAs can be summarised as
- Exchange of information for mutual recognition of GMP inspections
- Type of information to be provided + format of inspection reports
- Restrictions on data to be provided
- Information based on inspection – conducted to agreed method
What MRA inspection can cover + any limitations
Powers of the inspection authorities (national regulations etc.)
* Qualifications, experience and training of GMP inspectors
* Monitoring of inspection standards (quality management)
* Principle that national inspections = provisions of MRA
Where an MRA exists, some points to note are
A Manufacturing Authorisation for importation (UK: Wholesale Import Licence) continues to be required for products coming from Third Countries. Such authorisations require the services of a QP and he/she is still required to “formally release each batch for sale”
* “GMP Certificates” (viz authorisations of some sort to manufacture the relevant product(s)) issued by Third Country Regulatory Authority are required. Thus care needs to be taken by the EU Importation Company/Import QP to ensure that the Third Country Manufacturer holds and continues to hold such an authorisation in the Third Country
* Each case will need to be judged in the light of specific circumstances but typically:
QP Certification/Batch Release continues to be required within the EU
Full qualitative/quantitative analysis is unlikely to be needed
The administrative details within the MAA may need to be varied to add the exporting company as a site for testing
Some testing may still be appropriate (e.g. for heat sensitive products etc)
Checks will still be needed upon receipt (e.g. appearance, visual identity, condition/damage, adverse transport etc.)
A Certificate of Analysis will be needed for each batch
