Grounds for assessment

Criteria

1. the medicinal product is suitable for self‍-‍medication

2. serious side effects are rare when using the medicinal product

3. it is suitable in terms of patient safety and the protection of public health.

Criteria a) and b) must also be satisfied in respect of medicinal products which are currently sold over the counter in pharmacies.

Criterion c) leaves room for interpretation. To make it easier for the sector, the Swedish MPA makes it clear how the criteria are interpreted by setting out six principles.

Principles

1. Temporal aspect
   Medicinal products containing substances which have not been sold over the counter for a sufficiently long period of time (usually 3 to 5 years) in Sweden should not normally be sold outside pharmacies. In this regard, however, experience from the rest of the EU is also taken into account in the assessment.
2. Adverse effects
   Medicinal products which have adverse effects in the event of long‍-‍term use should not be sold outside pharmacies unless this risk can be reasonably be managed by limiting the package size.
3. Misuse
   Medicinal products in respect of which there is reason to suspect that misuse is taking place should not be sold outside pharmacies unless this risk can be reasonably managed by limiting the package size.
4. Development of resistance
   Medicinal products which contain anti‍-‍bacterial, anti‍-‍fungal, anti‍-‍viral and anti‍-‍parasitical, including anthelmintic, substances, should not normally be sold outside pharmacies. This is because of the development of resistance.
5. Prescription medicinal products
   Typical prescription medicinal products should not be sold outside pharmacies.
6. Counterfeit products
   In order to limit the risk of counterfeit medicinal products entering the lawful supply chain, medicinal products which have been subject to counterfeiting must be fitted with extra security features, that is to say a security seal or unique identifier. These products may only be sold in pharmacies. At present, there are only a few non-prescription medicinal products which must be marked with security features and therefore may not be sold outside pharmacies in Sweden. They are listed in EU Commission Regulation 2016/161.

The basic difference between sales of medicinal products outside pharmacies and sales in pharmacies is that there is no access to pharmaceutical advice. The lack of advice in combination with the above principles is often decisive to the assessment.

The need for medicinal products for the treatment of acute conditions to be available is also taken into account.

The criteria and principles are reviewed regularly and changed where necessary.