08/07/2022
EMA/PD/0000097966
EMADOC-360526170-1090618
Committees and Quality Assurance Department
Krisztián Balázs
Abacus Medicine A/S
Kalvebod Brygge 35
1560 Copenhagen V
Denmark
Notification of 01/07/2022 for:
Product Name | Remsima |
Product Strength | 100 mg |
Product Dosage Form | Powder for concentrate for solution for infusion |
Product Pack Size | 1 vial |
EU number | EU/1/13/853/001 |
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Liechtenstein, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Netherlands, Ireland, UK (Northern Ireland) | |
Member State(s) of destination1,2 | Lithuania |
Repackager(s) | Abacus Medicine B.V., Abacus Medicine Hungary Kft. |
Repackaging method | Reboxing |
Dear Krisztián Balázs,
Further to your submission of a notification for parallel distribution of the above-mentioned Centrally Authorised Medicinal Product, we hereby notify you that the regulatory check by the European Medicines Agency has now been completed.
As the above-mentioned Centrally Authorised Medicinal Product is a biological medicinal product (e.g. a vaccine, monoclonal antibody or blood product), the parallel distributor should inform, if applicable, the Official Medicines Control Laboratory (OMCL) of the Member State of destination on the parallel distribution of the product and to provide the OMCL with the following information for each batch: name of the medicinal product, strength, pharmaceutical dosage form, pack size, EU number, name and address of the marketing authorisation holder, manufacturer and parallel distributor, Member State of origin, batch number, expiry date, batch size (number of packages to be parallel distributed).
Please be aware that during the assessment of the above-mentioned medicinal product it has been decided that an educational programme will be put in place. The Marketing Authorisation Holder (MAH) has the legal responsibility to produce and distribute this educational material (e.g. physician’s pack, patient alert card, etc) to the concerned parties. Therefore, we strongly recommend that you liaise with the MAH for the distribution of the educational material to patients and contact the National Competent Authorities in the Member State of Destination, as there might be some additional responsibilities for parallel distributors under the national legislation.
We take this opportunity to remind you that a Centrally Authorised Medicinal Product may be distributed in parallel only if it is in conformity with the latest annexes to the Community Marketing Authorisation for the product. For this purpose, the Agency will prospectively provide such annexes to all parallel distributors.
It is the parallel distributor’s responsibility to verify that their supplier of the medicinal product complies with the principles and guidelines of good distribution practices and that they hold an authorisation. Due diligence checks should be carried out in order to assess the suitability, competence and reliability of the other party.
Once a year you must send a completed annual update form and supporting documentation to the
Agency for review, provided that the information supplied previously to the Agency has changed (e.g. change in repackager, package leaflet, labelling, etc.). The annual update notification should be completed per product, pharmaceutical form and Member State of Destination. In addition, you must submit safety updates relating to amendments to the Marketing Authorisation as communicated by the Agency.
We would also like to remind you that, according to the current case-law of the Court of Justice of the European Communities, the trade mark owner must be given advance notice by the parallel distributor that the repackaged product is to be put on sale. We should highlight that this regulatory check is without prejudice to the rights of the trademark owner.
Further information is available in the Post-Authorisation Guidance on Parallel Distribution on the Agency's website http://www.ema.europa.eu.
The authenticity of this notice may be verified in the public register of parallel distribution notices on the IRIS website: https://iris.ema.europa.eu/registerpd/. If it does not appear, please contact the European Medicines Agency via our online form: Send a question to the European Medicines Agency
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. ↑
Where United Kingdom (Northern Ireland) “UK(NI)” is a member state of origin, it should also be noted that medicinal products placed on the UK market by 31 December 2020 may still be subject to parallel distribution into EU/EEA and Northern Ireland based on the provisions foreseen in the Withdrawal Agreement. ↑