Approval of packaging for dose dispensing of medicines

Updated 28 May 2018

The Danish Medicines Agency publishes information on new types of containers for dose dispensing on the Danish Medicines Agency’s webpage pursuant to section 118(2) of the executive order no. 1108 of 29 September 2017 on prescriptions and dose dispensing of medicinal products.

The following containers are approved:

  • VMI Pharma Group, Netherlands: PE/PET-container
  • Medidos, Kibodan A/S: Styrene Acrylonitrile/HDPE
  • Medimax, Kibodan A/S: Styrene Acrylonitrile/PP
  • FDS P1601, Baxter, The Netherlands, cellophane/PE laminate
  • Apodos, Nomeco, Denmark: A-PETP container with a reverse side made of paper
  • Plain Cellophane, Tosho, Japan: PE/PE laminate
  • ATC 212, Baxter, The Netherlands, Cellophane/PE laminate
  • Apodos, Nomeco, Denmark: A-PETP non-perforated container with a reverse side made of paper
  • Swisslog Polypropylen film, Swisslog Italia S.p.A., Italy: single dose PP bag.
  • Airlier, Tosho, Japan: PET/PE-Container
  • Cellophane Roll, Farmadosis, Korea: Cellofan/LDPE

Additions to the list will continually be published here on the website.

Application for approval of packaging for dose dispensing

Please send the application to the contact person and make sure that you include the following information/documentation:

It must clearly be stated, what the material is made of. With regard to plastic materials, the names of all monomers must be stated, if the packaging consists of more than one.

Please enclose a specification containing:

  • A description of the packaging (name(s) of the material(s), thickness of layers, etc.)
  • A method (e.g. IR) for identification of the material which the packaging is made of
  • Characteristic properties, such as mechanical and physical properties

Documentation proving that the quality of the material is suitable as packaging for medicinal products. If the materials comply with the specifications in the Ph. Eur., you can refer to them.

If the material does not comply with one of the Ph. Eur. specifications, it is sufficient for solid dosed medicines that the plastic material complies with the requirements for plastic materials intended for use with food, i.e. the European food legislation in this area.

The documentation must state that the plastic monomers which the packaging consists of comply with these requirements and it is important to refer to relevant legislation, i.e. Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

Links

Danish Drug Standards on requirements for packaging for medicinal products

The following links are useful in connection with plastic packaging:

CPMP/QWP/4359/03 & EMEA/CVMP/205/04, Guideline on plastic immediate packaging materials.

Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance).

Q&A on EMA's website concerning packaging for solid dosed medicinal products, see the question concerning Packaging.

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