• Information to MAHs for new combined hormonal contraceptives

    | 29 January 2014 |

    After the most recent EU review of a number of new combined contraceptives under Article 31 of Directive 2001/83/EC, it was decided that marketing authorisation holder (MAHs) for these products must send out DHPCs and guidance material to doctors.

  • Time slots for DCP procedures with Denmark as Reference Member State (RMS)

    | 28 January 2014 |

    The Danish Health and Medicines Authority wishes to inform future applicants of the possibility to request for a time slot to applications for marketing authorisations through the decentralised procedure (DCP) where Denmark is acting as reference member state (RMS).

  • Questions and answers to new good distribution practice guidelines

    | 27 January 2014 |

    The guidelines on good distribution practice of medicinal products for human use came into force on 7 September 2013. Read our questions and answers to the guidelines.

  • Reimbursement of medicines bought in another EU/EEA country

    | 16 January 2014 |

    From 1 January 2014, you can obtain reimbursement of prescription-only medicines bought in another EU/EEA country under the general reimbursement rules of the Danish Health Act. You have to be covered by the national health insurance in Denmark and have a health insurance card (the yellow card) and the medicine must be reimbursable in Denmark.

  • Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

    | 15 January 2014 |

    On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products with the authorisation IDs 25081 and 25082 granted to Singad Pharma ApS (company number 255894).

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