LEGISLATION | Draft Order including new substances in Annex 1 of Royal Decree 2829/1977, of 6 October, regulating psychotropic substances and preparations, as well as the control and inspection of their manufacture, distribution, prescription and dispensing.
Last week ended the deadline for submitting comments on the draft Order adding new substances to Annex 1 of Royal Decree 2829/1977 of 6 October, which regulates psychotropic substances and preparations, as well as the control and inspection of their manufacture, distribution, prescription and dispensing, with final approval still pending.
It should be noted that the aim of this regulation is to strengthen control over the circulation and trafficking of psychotropic substances and preparations by expanding the list of such substances included in Annex 1.
ADVERTISEMENT | Reminder for the presentation of the annual index
In accordance with Royal Decree 1416/1994, of 25 June, regulating the advertising of medicines for human use, laboratories holding marketing authorisations for medicines or their local representatives are required to submit an annual index of all advertising activity for the previous year to the Department of Health's Medicines Surveillance and Advertising Section during the first quarter of 2026.
It is important to note that this index must include sponsorships within all advertising activity and must be accompanied by a list of advertising activity, which consists of a list of the different activities carried out and reported to the supervisory body.
In order to avoid penalties, all laboratories and/or local representatives must comply with this obligation.