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Inspection of authorised pharmaceutical companies

Updated 17 April 2012

The frequency of inspections of authorised pharmaceutical companies is determined on the degree of risk which the company's activities pose to patients. Consequently, it has been decided internationally that manufacturers of medicinal products must be inspected every two to three years. Wholesalers and retailers must be inspected every four to five years.

However, all pharmaceutical companies are inspected before authorisation and the first inspection after authorisation is usually performed within a shorter period. Retailers are inspected within the first 18 months.

Retailers are only authorised to purchase medicinal products with a marketing authorisation from the approved basic range, and only from authorised wholesalers in Denmark. Therefore, the risk of harm to patients from this activity is assessed to be low.

However, if the Danish Health and Medicines Authority has reason to believe that something is wrong, e.g. due to complaints or the like, the pharmaceutical company is inspected earlier than planned. The time of the next inspection is determined based on a risk assessment after each individual inspection so that the pharmaceutical company can be inspected more frequently if necessary.