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)

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 (about 100 million packs/year), systems and procedures are involved. It is therefore crucial to plan and prepare implementation as much as possible.

Contract with e-VIS

e-VIS sent out a large amount of letters in February 2018 to representatives or MAH respectively. The letter contained information but also some questions related to the company. We have received a lot of answers and we are now handling them. If you have not received a letter please contact info@e-VIS.

Information about the Swedish Pilot

See the document “Questions from MAH:s regarding the Swedish Pilot” to the right.

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)