Pharmaceutical Companies (MAHs)
Many preparations are needed in order for companies and other stakeholders to meet the requirements of the directive in February 2019. A large number of packs, systems and procedures are involved. It is therefore crucial to plan and prepare implementation as much as possible. A great deal of this work should have been started already or must be started urgently.
Pharmaceutical companies (MAH)
As of 9 February 2019, marketing authorised holders are obliged to place two safety features on the packaging of most prescription medicines and some over-the-counter medicines in the European Union: a unique identifier (a 2-dimension barcode) and an anti-tampering device, in accordance with Commission Delegated Regulation (EU) 2016/161. The goal is to prevent falsified medicines from reaching patients through the legal supply chain.
Each MAH which markets at least one product within a national territory must have a contract with the National Medicines Verification Organisation (NMVO) and pay the national fee.
Contract with e-VIS
For enquiries and information about on-boarding with e-VIS, send an email to firstname.lastname@example.org
Preparations for companies
Manufacturers of medicines covered by the Regulation
- Establish an interface to the European Hub according to the requirements from the EMVO
- Identify the “On-Boarding Partner” within the company and the point of connection to the European Hub
- Execute the Contract process and Technical on-boarding according to the EMVO requirements
- Develop procedures for uploading information about safety features to the European Hub for the packs to be released for sale – and only these, not discarded packs, reference samples, etc.
- Initiate serialisation and uploading to the European Hub as soon as possible to support the establishment of the Swedish system
- If products labelled with safety features were released to the Swedish market before the Swedish verification system (SMVS) is established, procedures must be in place to ensure that all information about these packs is uploaded to the European Hub as soon as the SMVS is operational.
Marketing Authorisation Holders (MAHs) or other parties responsible for products on the Swedish market
- Ensure that the manufacturers involved, including contract manufacturers outside Europe, can meet the requirements of the Regulation according to the applicable time schedule
Marketing Authorisation Holders (MAHs) who engage contract manufacturers
- Check/ensure the contract manufacturer’s implementation plans
- Decide on how information about safety features will be uploaded to the European Hub – usually via a contact point for the product owner’s company. (See information about On-Boarding to EU Hub)
14 June 2019