As of 1 January 2020, medicines with only one active ingredient can be sold for treating coughs and colds.
Based on the advice by the committee for medicines for human use, the FAMHP decided that combined preparations for treating coughs and colds must be removed from the market before 1 January, 2020. By that date, marketing authorisation holders (MAHs) must return their affected marketing authorisations (MAs) to the FAMHP.
Following the revision of the benefit/risk balance of medicines for treating coughs and colds, the MAHs of these medicines must submit a file with a new composition (change to a single preparation with one active ingredient) or prove that their preparation meets the requirements in the directive published by the European Medicines Agency (EMA): Guideline on clinical development of fixed combination medicinal products (February 2009).
Not one MAH has demonstrated a preparation meets the requirements in the aforementioned directive. A number of MAHs have submitted a file requesting an authorisation for a single preparation.
Combined preparations to be removed from the market:
- Acatar 15mg/5ml;50mg/5ml syrup,
- Broncho-Pectoralis Pholcodine 15mg/300 mg syrup,
- Inalpin 9.48mg/15ml;94.8mg/15ml syrup,
- Longbalsem 10mg/15ml;100mg/15ml syrup,
- Noscaflex Expectorans syrup,
- Pholco-Mereprine syrup (based on the elements and the procedure, the combined formula will be available until the end of May 2020),
- Toplexil syrup.
As reported on 27 March, 2018 officinal preparations for treating coughs and colds can contain only one active ingredient starting 1 January, 2020.