Skip to content

MAH

Each Marketing Authorisation Holder (MAH) which markets at least one product covered by the Falsified Medicines Directive (FMD) within a national territory must have a contract with the National Medicines Verification Organisation (NMVO) as from February 9th, 2019.

e-VIS (e-Verifikation i Sverige) is the Swedish non-commercial association who manages the SMVS (Swedish Medicines Verification System)

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.

e-VIS (e-Verifikation i Sverige) is the Swedish non-commercial association who manages the SMVS (Swedish Medicines Verification System).

Contract

Enquiries and information about on-boarding send an email to administration@e-vis.se

Information needed:

  • Full name of MAH*
    *Based on information given to the Swedish Medical Product Agency (Läkemedelsverket)
  • Address
  • VAT number, if not applicable company registration number

Annual fee

e-VIS charges an adjusted flat fee model per MAH.

The costs of the repositories system shall be borne by the manufacturers of medicinal products bearing the safety features, in accordance with Article 54a(2)(e) of Directive 2001/83/EC.

The adjusted flat fee per MAH 2024 remains unchanged compared to the 2023 fee.
The annual fee for 2024: SEK 63 000 (currency: Swedish krona)

The adjusted flat fee per MAH 2023 remains unchanged compared to the 2022 fee.
The annual fee for 2023: SEK 63 000 (currency: Swedish krona)

Companies with registered net sales less than SEK 1 000 000 (one million) can apply for a reduced fee. Detailed information and instructions in the annual fee document.
To apply for a reduced fee, notify e-VIS at administration@e-vis.se

e-VIS årsavgifter för MAH/Annual fees

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
  • If products labelled with safety features were released to the Swedish market before 9 February 2019 ensure that these packs are uploaded retrospective

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)

1. Costs

1.1. The pharmaceutical industry is responsible for the cost of the databases. What is the cost?

The pharmaceutical industry is responsible for the cost of the databases, Article 54a(2)(e) of Directive 2001/83/EC.

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.

e-VIS charges a flat fee per MAH.

For detailed information see the Annual fee for the current year.

1.2. When do you start to pay?

The annual fee shall be paid to e-VIS when the contract is signed.

1.3. Are there additional fees that the company should plan for?

e-VIS charges a flat fee per MAH and no additional fees.

EMVO charges a one-time on-boarding fee.  Further details at Knowledge DB

2. Auditing e-VIS

2.1. Should e-VIS be qualified and inspected as a supplier by manufacturers or other actors (end-users)?

The below answer has been prepared in consultation with the Medical Products Agency.

There is no requirement for an actor having an agreement with e-VIS to regularly audit e-VIS.

The main rule is that a supplier who performs a service on behalf of an actor, who is responsible according to the regulations, must be audited regularly. Auditing is done in relation to the agreement, but also in relation to the applicable regulations that govern the requirements of the service.

In operating the national repositories system for safety features, e-VIS does not perform any service on behalf of wholesalers, pharmacies or other actors, in the sense that e-VIS takes on a task that according to the delegated regulation is the responsibility of any of the other actors. The tasks performed by e-VIS according to the regulation (EU) 2016/161 are direct requirements specified for e-VIS.

Based on the above reason auditing of e-VIS is not regulated in MAH agreements or Terms and Conditions agreed with end users. Agreements should be updated with details on audit performance in case an audit after all is agreed between e-VIS and the actor having an agreement with e-VIS. In addition, such audit should be coordinated in order that as many actors as possible would benefit from the audit and as small disturbance in e-VIS activities as possible.