Contact
Online
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).
S’han de comunicar tots els materials que incloguin publicitat de medicaments, que vagin adreçats a persones facultades per prescriure o dispensar medicaments, als professionals de podologia i odontologia, o a les infermeres i als infermers de qualsevol naturalesa (paper, digital o electrònic), tant si s’hi inclou publicitat documental com publicitat de record.
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).
They can be reported whenever it is necessary to modify or correct advertising material that has been previously submitted.
If the laboratory wishes to modify the promotional material:
- Modified promotional material
- Scientific service report
If the laboratory wishes to modify any information in the form but the promotional material is not modified:
- Scientific service report
This procedure is free of charge.
- General legislation on advertising
• Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising.
• Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market.
• Directive 2018/1808 of the European Parliament and of the Council of 14 November 2018 amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive), in view of changing market realities.
• Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce).
• Law 34/1988, of 11 November, General Advertising Law.
• Law 3/1991, of 10 January, on Unfair Competition.
• Law 13/2022, of 7 July, General Audiovisual Communication Law.
• Law 34/2002, of 11 July, on Information Society Services and Electronic Commerce.
- Nursing guidelines
• Royal Decree 1302/2018, of 22 October, amending Royal Decree 954/2015, of 23 October, regulating the indication, use and authorisation for dispensing of medicinal products and medical devices for human use by nurses.
• Resolution of 20 October 2020 of the Directorate-General for Public Health, approving the guideline for the indication, use and authorisation for dispensing prescription medicines by nurses: Wounds.
• Resolution of 30 June 2022 of the Directorate-General for Public Health, approving the guideline for hypertension and type 1 and type 2 diabetes mellitus.
• Resolution of 8 July 2022 of the Directorate-General for Public Health, approving the guideline for burns.
• Resolution of 22 December 2022 of the Directorate-General for Public Health, approving the guideline for ostomies.
• Resolution of 13 June 2023 of the Directorate-General for Public Health, approving the guideline for oral anticoagulation.
• Resolution of 26 October 2023 of the Directorate-General for Public Health, approving the guideline for fever.
• Resolution of 22 March 2024 of the Directorate-General for Public Health and Health Equity, approving the guideline for smoking cessation.
• Resolution of 22 March 2024 of the Directorate-General for Public Health and Health Equity, approving the guideline for diagnostic or therapeutic procedures requiring the use of local anaesthetics.
• Resolution of 9 August 2024 of the Directorate-General for Public Health and Health Equity, approving the guideline for uncomplicated lower urinary tract infection in adult women.
Steps to follow
-
1
Step one
Notify modifications
This procedure can only be completed online. If you are a legal entity, you must sign the form using a digital representation certificate.
If you are signing on your own behalf, you must do so using a digital certificate.
By Internet
Notify modifications to previously submitted advertising materials
Start . Go to Notify modifications to previously submitted advertising materialsStep 1: Fill in the online form
- Identify yourself using a digital certificate.
- Fill in the form:
• No need to download it. Fill it in directly online. - Attach the documentation:
• Click the “Attach” button and locate the document on your computer.
• Make sure the file name does not contain spaces, hyphens, accents, or umlauts. - Submit the form:
• If any mandatory information is missing or any data is incorrect, you will see an error message and the fields to review will be highlighted. - Signature:
• Sign the form using a digital certificate. You can consult the page “How to digitally sign an HTML form” for more information. - Assistance in case of doubt:
• If you have any questions, consult the section “Forms completed through the website” on Tràmits gencat.
Step 2: Confirm the completed procedure
- Registration receipt:
• If the application has been submitted correctly, the registration receipt will appear on the screen (you need Adobe Acrobat to open it). Save or print this document, as it contains the entry record (start date of the procedure) and the procedure identification code (to check the status of the procedure in the Private Area). - Errors in the application:
• If the application contains any errors, it will not be submitted and an error message indicating the issue will appear.
If you experience technical issues, try again later or check whether there is any service interruption in the notices section of the electronic headquarters.
For any questions or technical issues, consult the support website or call 012.
-
2
Step two
Consulta l'estat del tràmit
Per fer el seguiment de les teves gestions i tràmits, pots accedir-hi a través de:
Per fer el seguiment de les teves gestions i tràmits, pots accedir-hi a través de:
- L'Estat de les meves gestions (amb l’identificador del tràmit i el DNI/NIF).
- Telèfon 012 (amb el codi identificador (ID) del tràmit i el DNI/NIF).
- L'Àrea privada (amb certificat digital o contrasenya d’un sol ús).
Consulta més informació sobre com accedir i fer seguiment dels meus tràmits.
-
3
Step three
Rep la resposta de l'Administració
¿Quan rebràs la resposta?
¿Quan rebràs la resposta?
La comunicació del material publicitari no produeix cap resposta de l’Administració.
Un cop comunicat el material publicitari no cal que esperis cap autorització respecte d’aquesta comunicació.
