Legal & Tax Alerts

The registration of manufacturers, importers and distributors of active substances used in medicinal products for human use, subject to new rules

Manufacturers, importers and distributors of active substances that will be used as raw materials in medicinal products for human use will follow, for registering their activity, new rules as of 12 June 2019,  according to Order no. 775/2019 (“Order no. 775/2019”) of the Ministry of Health.

For registering their activity, manufacturers, importers or distributors of active substances must submit to the National Agency for Medicines and Medical Devices (“NAMMD”) a registration form whose model is enclosed to Order no. 775/2019, accompanied by a series of administrative and technical documents.

The deadline for submitting this documentation is of at least 60 days prior to the date envisaged for initiating the activity, respectively of 30 days as of the date Order no. 775/2019 entered into force (i.e. 11 June 2019), in case the economic operators were already carrying out this activity when it was adopted (i.e. 20 May 2019).

The manufacturers, importers and distributors of active substances have to annually submit to NAMMD a list of the changes that occurred regarding the information provided in the registration form. Any change that might have an impact on the quality or safety of the manufactured, imported or distributed active substances must be immediately notified.

You can read and download this legal alert in PDF format right here.

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