Drug shortages are an important issue since the COVID-19 pandemic.
According to the Medicines Act, each Marketing Authorisation Holder (MAH) and Wholesaler must ensure that sufficient supply of each medicine is available. The interpretation of ‘sufficient supply’ is now articulated in a policy rule, with a quantified stock obligation for prescription medicines. On 1 January 2023, this rule comes into force.
Responsibilities for MAH’s:
- Adequate supply to wholesalers and pharmacies to meet patients’ needs
- 6 weeks of stock to be retained
- Calculation method: all deliveries from the past year / 52 x 6
- Stockholding obligation applies to all individual marketing authorisations (Single drug, multiple strengths/medication forms > Stockholding obligation applies to each RVG number!)
Responsibilities for Wholesalers:
- Each strength and administration form
- Adequate supply for delivery to pharmacies
- 2 / 4 weeks of stock to be retained
- Calculation method: all deliveries from the past year / 52 x (2)/(4)
> Tiered introduction: 2 weeks on 1-JAN-2023 and 4 weeks as from 1-JUL-2023
The first year, 2023, is considered a pilot year: the Inspectorate will do pilot inspections to gather information for the periodic evaluation. No fines will be imposed.
This means you either ‘comply’ with this new requirement or ‘explain’ why you don’t.
Source: Aanleg ijzeren voorraad geneesmiddelen verplicht per 1 januari 2023 | KNMP