Inspection of authorised pharmaceutical companies
Pursuant to the Danish Medicines Act, the Danish Medicines Agency supervises that pharmaceutical companies comply with the rules governing the handling of medicinal products, including the manufacture, distribution and sale to consumers. Consequently, we inspect many different pharmaceutical companies, ranging from major pharmaceutical companies to small shops that sell over-the-counter medicines. We have granted these companies an authorisation pursuant to section 39 of the Danish Medicines Act, and we can therefore carry out inspections of the companies.
An inspection can take from half an hour to several days, depending on the complexity of the company and the risks associated with the company’s activities. At an inspection, our inspector reviews the company’s quality system, including whether relevant procedures have been written down and are complied with. Typically, the inspector will make random checks to clarify whether procedures and rules are complied with.
After the inspection, the inspector prepares an inspection report, describing any deviations. Some deviations may be so severe that we impose a fine on the company, place medicinal products in quarantine, withdraw medicinal products from the market, suspend the authorisation or impose other sanctions to improve patient safety.
We fix the time interval between inspections of pharmaceutical companies according to the risk we assess that the company’s activities may pose to patients and consumers. However, it has been decided internationally that manufacturers of medicinal products must be inspected every three years as a minimum. We use similar risk-based systems for the inspection of wholesalers and retailers, but they are inspected less frequently.
Pharmaceutical companies are normally inspected before authorisation, that is before the company starts to handle medicinal products. Retailers complete an e-learning module about the rules in this field before they are granted authorisation.
Changes requiring an inspection
When a pharmaceutical company has been authorised by us to carry out activities with medicines, it cannot change the authorisation's terms without our approval. Such a situation could arise if the company wants to include the manufacture of new types of formulations, or if the company wants to relocate or change its name. Any such changes must be applied for first, and the new terms must be approved on the company authorisation before the changes can be implemented.
The company can moreover effect changes that do not require the company authorisation to be changed, but still require notification to the Danish Medicines Agency and perhaps even an inspection.
Changes requiring an inspection in the GMP area
Below you will find an overview of the type of changes in the GMP area that we assess will require you to submit information to the Danish Medicines Agency and perhaps even necessitate an inspection before the changes can be implemented. Please be aware that it is not an exhaustive list and that some changes on the list may require the manufacturing authorisation to be changed as well, e.g. if a new production room is placed at a new geographical location, thus to be authorised as a new site on the authorisation.