Information for marketing authorisation holders concerning ways of introducing blue-box information on medicinal product labelling

SÚKL hereby informs marketing authorisation holders about an update to the guidance laying down blue-box requirements for medicinal product labelling.  

The State Institute for Drug Control (hereinafter referred to as “SÚKL”) informs about an update to the guidance laying down blue-box requirements that have been updated with a view to legislative amendments and harmonisation of requirements governing medicinal products authorised via MRP/DCP/national procedures with those governing medicinal products authorised via the centralised procedure.

Medicinal products authorised via the MRP/DCP/national procedure

Blue-box requirements for the labelling of medicinal products authorised via the national procedure, DCP or MRP are set forth by CMDh guideline “Blue-Box” requirements, available from here.

Blue-box information required for these medicinal products shall be provided in the texts on the labelling (product information), except for SÚKL code. The information does not have to be shown in the blue frame as is the case of medicinal products authorised via the centralised procedure.

The following blue-box requirements apply in the Czech Republic:

1)      Price

  • Specification of the price of the medicinal product on the labelling is not required.

 

2)      Reimbursement

  • Specification of the reimbursement of the medicinal product on the labelling is not required.

 

3)      Legal Status

  • Specification of the general classification for supply of the medicinal product on the labelling is not required.
  • If the labelling does show the general classification for supply, the wording must comply with Annex 5(A)(8) of Decree No 228/2008 Coll., on marketing authorisation of medicinal products, as amended.
  • More information about introducing the general classification for supply on medicinal product labelling is provided here.

 

4)      Identification and authenticity

  • In case that identification of the medicinal product is not ensured via a unique identifier as part of the safety features (i.e. the medicinal product does not bear safety features), the labelling must include an internationally recognised identification standard, such as the EAN or 2D code.
  • Where the medicinal product bears safety features, the EAN code does not have to be shown on the labelling.
  • The printed version of the labelling has to show the code allocated pursuant to Section 32(5) of Act No 378/2007 Coll., on Medicinal Products and on Amendments to Some Related Acts, (Act on Pharmaceuticals), as amended (so called “SÚKL code”).
  • SÚKL code has to be shown on the printed outer packaging, or on the immediate packaging if no outer packaging exists. SÚKL code is not included in the approved texts of the labelling and it does not have to be shown on the mock-up.
  • To facilitate identification, SÚKL recommends to introduce the numerical code with the prefix words “SÚKL kód:”.

 

5)      Special precautions for disposal of unused medicinal products or waste materials derived from such medicinal products

  • The outer packaging or the immediate packaging where no outer packaging exists shall show the sentence “Nepoužitelné léčivo vraťte do lékárny” (“Any unused medicinal product should be returned to the pharmacy”), if relevant for the concerned medicinal product.
  • Where the return of unused pharmaceuticals to a pharmacy does not apply to the medicinal product, the sentence above does not have to be shown on the labelling.

 

6)      Additional requirements

  • In addition to the information described above, SÚKL may require the provision of other information on the labelling and in the package leaflet of the medicinal product.
  • Such additional requirements shall be determined on an individual basis for the concerned medicinal products, as appropriate.

 

Medicinal products authorised via the centralised procedure

Blue-box requirement for the labelling of medicinal products authorised via the centralised procedure are set forth by European Commission guidance document Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Union, available from here.

Required Blue-box information on these medicinal products is not to be included in the texts on the labelling (product information); the information should be accommodated on the label in a single box with a blue border (frame), present on one side of the outer packaging only; the information has to be in the Czech language and the name of the country for which the information is being provided should be specified (e.g. “ČR”, “CZ” or “Česká republika” (Czech Republic)).

The following blue-box requirements apply in the Czech Republic:

1)      Price

  • Specification of the price of the medicinal product on the labelling is not required.

 

2)      Reimbursement

  • Specification of the reimbursement of the medicinal product on the labelling is not required.

 

3)      Legal status

  • Specification of the general classification for supply of the medicinal product on the labelling is not required.
  • If the labelling does show the general classification for supply, the wording must comply with Annex 5(A)(8) of Decree No 228/2008 Coll., on marketing authorisation of medicinal products, as amended.
  • More information about introducing the general classification for supply on medicinal product labelling is provided here.

 

4)      Identification and authenticity

  • In case that identification of the medicinal product is not ensured via a unique identifier as part of safety features (i.e. the medicinal product does not bear safety features), the labelling must include an internationally recognised identification standard, such as the EAN or 2D code.
  • Where the medicinal product bears safety features, the EAN code does not have to be shown on the labelling.
  • The code allocated pursuant to Section 32(5) of Act No 378/2007 Coll., on Medicinal Products and on Amendments to Some Related Acts, (Act on Pharmaceuticals), as amended, so called “SÚKL code” has to be included.
  • To facilitate identification, SÚKL recommends to introduce the numerical code with the prefix words “SÚKL kód:”.

 

5)      Special precautions for disposal of unused medicinal products or waste materials derived from such medicinal products

  • Where no special precaution for disposal of the medicinal product applies, the sentence “Nepoužitelné léčivo vraťte do lékárny” (“Any unused medicinal product should be returned to the pharmacy”) shall be shown on the packaging.

 

Marketing Authorisation Section

10th June 2021