When completing the form, the EU country that should be declared as the export country is the one in which the medicinal product packs are procured.
1. How is the export country for parallel-imported medicinal products defined if the products have been authorised in the EU by the EMA according to the centralised procedure (CP)?
2. When must the test samples be submitted to the laboratory (OMCL)?
3. How many test samples must be submitted? Revised in May 2025
4. If measures*) according to the guidance document RMP ICH E2E Information for submission HMP have been implemented for the original medicinal product (first applicant), do these have to be adopted for the parallel-imported medicinal product too? New, 1 June 2025
5. If the packaging of the original medicinal product (first applicant) has mobile technologies on it, do these have to be adopted for parallel-imported medicinal products too? New, 1 June 2025
6. What is the procedure for labels on the folding carton of the parallel imported medicinal product if there are mobile technologies on the folding carton of the foreign packaging? New, 1 June 2025
The samples must be sent to the OMCL simultaneously, i.e. not more than three days before or three days after the submission of the application documentation.
In principle, one sample pack per dosage strength and per export country must be submitted. Moreover, care should be taken to ensure that the shelf-life of the samples submitted covers the duration of the authorisation process. Depending on the dosage form, dosage strength, number of individual doses contained in each pack and/or the duration of the process up until the end of the formal control, Swissmedic may have to request further samples.
*) particularly the following:
- Pharmacovigilance plan with the measures described in it (for example, risk-specific questionnaires (specific / targeted follow-up questionnaires))
- Risk minimisation measures (e.g. appropriate warnings in the Information for healthcare professionals and Patient information, packaging material design, additional measures such as patient information cards, officially ordered information material)
Yes
Yes, in accordance with the guidance document Mobile technologies.
Any mobile technologies on the foreign packaging must not be visible.