REGISTRATION AND ARCHIVE SERVICE

DOCUMENT SUBMISSIONS-RELEASES:

MONDAY – THURSDAY: 9.30 – 13.30
Monday: Authorisations/Renewals/Variations – European procedures, pharmacovigilance, clinical trials, clinical trial sites (centres).
Tuesday: Authorisations/Renewals/Variations – national procedure, special needs authorisation, parallel import, clinical trial sites (centres).
Wednesday: Authorisations/Renewals/Variations – European procedures, pharmacovigilance, clinical trials, clinical trial sites (centres), advertising, educational materials.
Thursday: Authorisations/Renewals/Variations – national procedure, special needs authorisation, parallel import, clinical trial sites (centres).
FRIDAY – NOT OPEN TO THE PUBLIC

DOCUMENT SUBMISSIONS-RELEASES – other document types:

MONDAY – THURSDAY: 9.30 – 13.30

RELEASE OF PHARMACEUTICAL INSPECTION DOCUMENTS:

TUESDAY, THURSDAY: 11.30 -13.30