If your application form is incomplete, you will be asked to complete it within 6 weeks. When the completed form has been received you will be sent an acknowledgement of receipt and your form will be submitted to the Health and Youth Care Inspectorate (IGJ). The OMC will decide on behalf of the Minister of Health, Welfare and Sport whether to grant the exemption, taking the IGJ’s advice into account.
Decisions on new applications are made within three months.
The Opium Act does not specify a deadline for processing applications to amend exemptions from the Act. The General Administrative Law Act (Algemene wet bestuursrecht) states that the deadline for such applications is a ‘reasonable period’, Farmatec-OMC have fixed this period at 90 days.
It should be noted that this deadline can be temporarily suspended if Farmatec-OMC or the IGZ are unable to process your application for reasons for which you are responsible (e.g. you are on holiday or carrying out renovations). The period will resume as soon as Farmatec-OMC or IGZ are able to proceed with your application. You will be informed in writing if Farmatec-OMC is unable to meet the deadline.
The cost of applying for an exemption from the Opium Act is €1.000,00. The same fee is charged for any application to extend the exemption if the total period of exemption will exceed a total of five years. In other words, the application fee must be paid once every five years. The fee will not be reimbursed if you withdraw your application, if your application is not processed or if your application is rejected in full or in part.
There is also an annual fee of €700,00 due on 1 January each year. If you no longer wish to use your exemption you must inform Farmatec-OMC of this, in writing, before 1 January of the calendar year in question. If you fail to do so you will be charged the annual fee due for that year.
If you apply to both OMC and Farmatec-OMC for an exemption, you will be required to pay the fee twice. If both exemptions are granted you will also be required to pay two annual fees.
Validity of the exemption
Exemptions from the Opium Act are valid for a maximum of five years. If you wish to continue working with substances specified in the Opium Act after this period you will need to submit an application to extend the exemption.
- International: the Single Convention on Narcotic Drugs and the Convention on Psychotropic Substances
- National: the Opium Act (Opiumwet), the Opium Act Decree (Opiumwetbesluit), the Opium Act Implementation Regulations (Uitvoeringsregeling Opiumwet) and the Policy Rules on Exemption from the Opium Act (Beleidsregels opiumwetontheffingen)