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What do you need to know?
Advertising of medicinal products means any form of informative offer, prospecting or inducement aimed at promoting the prescription, dispensing, sale or use of medicinal products.
The outcome of this reporting process does not in any case entail authorisation but rather a record of compliance with the obligation to make the notification and the date on which it was made. If the supervisory body finds that what has been reported does not meet the requirements, it notifies the company concerned so that it can make the appropriate changes.
Advertising of medicinal products includes:
- Advertising of medicinal products to the public.
- Advertising of medicinal products to persons qualified to prescribe or dispense medicinal products.
- Medical visits by medical sales representatives or laboratory information officers to persons qualified to prescribe or supply medicinal products.
- Sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, and in particular the payment of travel and accommodation expenses for such congresses.
- Sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products.
- The provision of free samples of medicinal products.
This procedure can only be done online. Any documents you submit through another channel will not be processed and will not be considered for the purposes of the date of submission.
When you send the form, you have to identify yourself with a digital certificate or idCAT Mobile if you are the owner of the company, or with the digital certificate of representation if you are its representative.
Remember that the company name must include the name of the pharmaceutical laboratory in charge of the advertising.
To correctly fill out the forms, you have to save them as a PDF on your computer with the name you choose and open them with an updated version of Adobe Reader (version 9.1 or more recent). If in doubt, please see the Adobe Reader setup instructions and the instructions for downloading PDF forms with your browser. Remember the folder where you have saved the files.
In case of questions, check the security recommendations available on “Tràmits gencat” or call the 012 helpline (calls from Catalonia), 93 214 21 24 (calls from outside Catalonia), or 00 34 93 214 21 24 (calls from abroad).
Authority responsible
Individuals and legal entities based in Catalonia that advertise medicinal products for human use.
These organisations are required to use electronic means of communication with government agencies to carry out any administrative procedure under Article 14.2 of Act 39/2015 of 1 October (BOE no. 236 of 2 October 2015) and Order PDA/20/2019 of 14 February (DOGC no. 7814, of 20 February).
The annual index of advertising activities must be submitted during the first quarter of the current year.
- Llistat de les activitats publicitàries
Documents to be attached to the notification:
- List of the advertising activity showing the activities conducted and reported during the previous year and drawn up by the laboratory
There are no fees associated
Complementary informationThere are no fees associated with this procedure.
- Royal Decree 1416/1994 of 25 June regulates the advertising of medicinal products for human use and confers powers on the Regions to supervise the advertising of medicinal products.
- Royal Decree 1047/1997 of 27 June on the transfer of functions and services from the Spanish National Government to the Government of Catalonia in enforcing legislation on pharmaceutical products confers authority on the Catalan Government to supervise promotion aimed at health professionals.
- In Catalonia, the Catalan Government’s Ministry of Health exercises these powers of legislation and supervision over the advertising of medicinal products in its territorial area through the Pharmaceutical Planning and Quality Service in the Directorate General of Health Organisation and Regulation.
Steps to follow
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Step one
Report the annual index of advertising activities
This procedure can only be done online. Any documents you submit through another channel will not be processed and will not be considered for the purposes of the date of submission.
When you send the form, you have to identify yourself with a digital certificate or idCAT Mobile if you are the owner of the company, or with the digital certificate of representation if you are its representative.
By Internet
Report the annual index of advertising activities
Start . Go to Report the annual index of advertising activitiesHow to do it
Step 1. Download, fill in and validate the form
- Download the form (if you have problems downloading it, check how to download PDF forms) and fill it out.
- Validate it (the form is only valid if you have filled in all the required information and attached all the required documentation). This notification must be accompanied by a list of advertising activities, including a list of the activities conducted and reported during the previous year and drawn up by the laboratory.
- This form requires the identification and authentication by means of the electronic signature of the owner or representative of the pharmaceutical laboratory responsible for the annual index being reported.
- Save it to your computer.
Step 2. Submit for processing
- Go back to the online procedure.
- Select the file containing the completed, validated and signed form and press the Submit button.
Step 3. Confirmation of the processing carried out
- If the notification has been successfully submitted, the acknowledgement of receipt will appear on the screen. It is important that you save or print it as this document contains the entry record, which is the date on which this procedure was begun and may be significant in certain calculations and deadlines, and the procedure identifier, which you can use to find out its status in the “Private Area” on this website.
- If the notification contains an error, it will not be sent and a message will come up stating what the error is.
If you have any queries about the procedure, first see the recommendations in the ‘Support’ section at Tràmits Gencat or call the 012 helpline.
Please note that a valid digital certificate is required to carry out online procedures. We recommend you check the various certificates accepted and the other conditions for online procedures.
Secondly, once you have checked that you have all the resources required and that you have completed the process as instructed, you can check whether there has been a service outage or incident in the Service Notifications and Outages section of the Seu Electrònica, where you will find all the information on types of incidents and where they have occurred; search for the service incidents for the year in question and sort them by the “Start date and time” field in descending order. If you cannot process it because of an incident in the system, please try again later.
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Step two
Check the status of the procedure
You can check the status of the procedure:
You can check the status of the procedure:
- In the Canal Empresa (with idCAT Mòbil and/or digital certificate)
- In Status of My Procedures (Canal Empresa) (with the procedure identifier and your DNI/NIF/NIE)
- In Status of My Procedures (Tràmits Gencat) (with the procedure identifier and your DNI/NIF/NIE)
- By calling 012 (with the procedure identifier and your DNI/NIF/NIE)
Procedure identifier
You will need to have the procedure identifier (procedure ID) which is a five-digit alphanumeric code that is generated when you submit your application and is unique.
You can use this code to check the history of the procedure.
For more information, please see the section on How to log in and track my procedures and idCAT Mobile in the Support for processing procedures section at Tràmits Gencat website.
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Step three
Get the reply from the agency
Under Royal Decree 1416/1994 of 25 June regulating advertising of medicinal products for human use, pharmaceutical laboratories holding the marketing authorisation for medicinal products are required [...]
Under Royal Decree 1416/1994 of 25 June regulating advertising of medicinal products for human use, pharmaceutical laboratories holding the marketing authorisation for medicinal products are required to submit the annual index of advertising activities performed. Once they have met this requirement, they do not have to wait for a reply.
Following the notification, the competent health authority may take any measures needed to confirm the veracity of the information supplied and also compliance with the specific requirements for the performance of operations under legislation applicable to the notification.
