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Notifications and penalties advertising
| 23.12.2024 |
To the attention of interested persons Considering the approval of Order of the Minister of Health no. 5930 of 11.12.2024 on amendment and supplementation of the Annex to Order of the Minister of Health no. 194/2015 on Rules for assessment and approval of advertising of medicinal products for human use, please be advised that the method of submitting sponsorship activity declaration forms has changed: Article 35, paragraphs (5) and (7) are amended and shall read as follows: ”(5) The declaration of sponsorship activities, as well as other expenses, other than sponsorship, made in line with the provisions of paragraphs (3) and (4), shall be made according to the forms whose pattern is provided in Annexes 1 and 2, by electronic signature, according to the provisions of Art. 3 points 11 and 12 of Regulation (EU) no. 910/2014, through online applications posted on the NAMMDR portal: portal.anm.ro.” Please use this method of submitting the declaration forms, the only way to submit the forms to the NAMMDR according to the legal provisions. Please consult the Completion Guide for both beneficiaries and sponsors before completing and submitting the declaration forms for sponsorship activities. |
| 08.03.2024 |
To the attention of interested persons Please be informed that the following forms have changed starting from 08.03.2024” 1. The application for approval of advertising for medicinal products for human use 2. The form for payment of the fee for evaluation of the advertising of medicinal products for human use |
| 20.12.2023 |
To the attention of interested persons We inform you that starting with 01.01.2024, the submission of advertising materials or educational materials for evaluation within the Advertising Service becomes mandatory, through the upload platform. Moreover, please be advised on the following: 1. The interval from the date the file receives a registration number to the date the advertising/educational material is uploaded using the upload platform must not exceed 3 days. 2. The advertising or educational material is uploaded through the upload platform both for materials submitted for endorsement/approval and for materials submitted for re-approval. 3. The title of the message on the upload platform must refer ONLY to the file’s registration number, without other details (name, nature of advertising, product, etc.) 4. Requests from the Advertising Service to the applicant and their replies are made ONLY by e-mail, not through the upload platform. |
| 28.11.2023 |
To the attention of interested persons Considering the approval of Law 269 of 10 October 2023 on amendment and supplementation of Law 95/2006 on healthcare reform, please be advised that, as of 01.01.2024, the updated provisions of Article 815 paragraph (1) point b) shall apply, which reads as follows: In line with the provisions of Art. 813, any advertising material for the general public shall: b) include at least the following information: – the name of the medicinal product, as well as the common name, if it contains a single active substance; – the information necessary for the correct use of the medicinal product; – an explicit and legible invitation to careful reading of instructions in the patient leaflet or the outer packaging, worded as follows: “This medicinal product is available without medical prescription. Careful reading of the patient leaflet or the information on the package is recommended. In case of any unpleasant manifestations, please contact your physician or pharmacist.” Expired and/or unused medicinal products are considered hazardous waste. |
| 06.07.2023 |
To the attention of interested persons Please be advised that, as of 10 July 2023, the Document Upload platform of the Advertising Service becomes active. For a 3-month period, applicants wishing to submit files containing advertising or educational materials for evaluation to the advertising service shall be able to submit them both ways: the classic way used so far and the newly proposed way. Following this transition period, submission of advertising or educational materials for evaluation within the advertising service through the UPLOAD platform becomes mandatory. Please find the user manual hereby attached: download document… 
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| 07.12.2021 |
To the attention of interested persons Concerning the current information, according to which information related to activities of sponsorship (and other expenses) of healthcare professionals, professional organisations, patient organisations and any other type of organisation carrying out activities related to human health, medical or pharmaceutical assistance by manufacturers, MAHs or their representatives in Romania, are unavailable on the NAMMDR website download document…
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| 01.04.2020 |
To the attention of interested persons The National Agency for Medicines and Medical Devices of Romania (NAMMDR) hereby informs on changing the deadline for submitting the forms to declare sponsorship activity for both medicinal products for human use and healthcare materials, in line with the provisions of Order no. 538/2020 for supplementation of some Orders of the Minister of Health which include regulations regarding sponsorship activities in the field of medicinal products for human use, medical devices and healthcare materials, published in the Official Gazette of Romania no. 267/31.03.2020. Thus, the new deadlines for submitting statements regarding sponsorship activities are: – 30 June 2020, for those concerning medicinal products for human use and which are transmitted to the NAMMDR; – 31 July 2020, for medical devices and healthcare materials, which are submitted to the Ministry of Health (MS), with the help of the special structure of the NAMMDR. The deadline for which the declared information can be posted on the NAMMDR website, respectively on the Ministry of Health’s website and on the websites of the entities that carried out the sponsorship activities and of their beneficiaries, as the case may be, was also amended. Thus, the new deadlines for publishing are: – 30 September 2020, for medicinal products for human use; – 31 October 2020, for medical devices and healthcare materials. |
| 28.08.2017 |
To the attention of interested persons Until this date, through the checks performed by the NAMMD on press notifications, the errors generated in the import of the data transmitted by the Linde company, in the NAMMD centralised data system in 2016 were identified and corrected. The errors were caused by the non -compliance with the Agency’s recommendations to fill in the forms. In order to ensure total transparency of the activity of managing these notifications, the NAMMDR shall continue to notify any possible error and to correct the register of sponsorship records, posted on the website. |
| 14.12.2015 | SC FITERMAN PHARMA SRL has been sanctioned for use of advertising channels unapproved by the NAMMD for SINDOLOR GEL. |
| 23.09.2013 | As of 2 December 2013, the National Agency for Medicines and Medical Devices intends to start checking the implementation of Article 611 of Decision no. 18/08.08.2013 on approval of the revised version of the Guideline on evaluation of advertising of medicinal products for human use. |
| 05.02.2013 | BIOFARM SA has been sanctioned for broadcast of unauthorised advertising materials via distribution channels unauthorised by the NAMMD for Bixtonim Xilo, nasal drops, solution |
| 05.01.2012 | For reasons of non-compliance with provisions of Article 30, i) of chapter III of SCD 21/2011 on approval of the Guideline on assessment of advertising for medicinal products for human use, withdrawal from broadcast in healthcare professional media of press mock-ups for the following medicinal products: – AULIN 100, tablets, (ANGELINI PHARMACEUTICALS ROMANIA SRL) – DUODART, 0.5 mg/0.4 mg, capsules, (GlaxoSmithKline SRL) – AMISULPRIDA LPH, 200mg, tablets, DEFROZYP, 75 mg, film-coated tablets, TRIGLIPO 160 mg, tablets, VOREDANIM 10 mg, 20 mg, 40 mg film-coated tablets, INDAPAMID LPH, 1.5 mg tablets (LABORMED PHARMA S.A.) – Oscilococcinum, homeopathic globules (Lab. BOIRON S.A) |
| 28.07.2011 | Terapia SA has been sanctioned for broadcast of a different TV spot version than authorised by the NAMMD concerning ASPENTER, film-coated gastroresistant tablets. |
| 31.03.2011 |
The workgroup for revision of the Guideline on assessment of advertising for medicinal products for human use established at NAMMD level between pharmaceutical companies representatives and NAMMD representatives, proposes the introduction of the definitions available in the Guideline subject to revision. We wait for the possible completions or modifications of the material on the email address nicolae.fotin@anm.ro until the date of 08.04.2011. download document…
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| 24.01.2011 |
Inspections performed by NAMMD inspectors at medicinal products of human use retail distribution units, have revealed as follows: use of advertisement not submitted to approval of the NAMMD, “kits” for various conditions – combinations of 3 medicinal products with reference to price reductions or “special prices” at both display and in brochures for the general public; use of advertising material for on-prescription only medicinal products in places for general access. For each of the medicinal products for which such advertising has been used, the NAMMD has sanctioned the marketing authorisation holder. fines for advertising breaches …
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| 05.11.2010 | Health Advisors SRL – has been sanctioned for failure to comply with NAMMD request of recall from broadcast of the TV spot in unauthorised format for NEOLIN tablets. |
| 03.11.2010 |
Medochemie LTD – the Representative to Romania – has been sanctioned for use of out-door advertising not approved by the NAMMD advertising Rupan 200mg, film-coated tablets. Dentotal Protect SRL – has been sanctioned for broadcast of unapproved NAMMD advertising material (audio and in print format) for ARTIDENTAL 40 mg/0.005 mg/ml solution for injection. |
| 01.11.2010 | Promomed SRL – has been sanctioned for distribution of unapproved advertising materials for the MEDIKINET RETARD capsules medicinal product. |
| 15.10.2010 | SC HEALTH ADVISORS SRL has been sanctioned for the distribution in another form than the one advised by NAMMD of one advertising material for NEOLIN. |
| 08.10.2010 | In attention of the market authorization holders for medicinal products and their representatives. The National Agency for Medicines and Medical Devices notifies you that, in order to provide easier communication between the parties involved in assessment/notice of the advertising materials for medicinal products of human use, it is necessary to assign a person responsible for this activity, as well as a deputy for this person. The nomination will comprise the contact data (name, surname, professional training, phone number, address, e-mail) and will be submitted to the NAMMD Registry during the program for receipt of advertising materials. |
| 27.09.2010 |
Therapia SA – has been sanctioned for the distribution of unapproved advertising materials for the Furazolidon 100mg tablets medicinal product. Terapia SA – has been sanctioned for the broadcasting of an unapproved radio advertising spot for CODAMIN P tablets. |
| 02.09.2010 | Biofarm SA – has been sanctioned for the use of unapproved advertising channels for the product BIXTONIM – nasal drops, solution. |
| 15.06.2010 | Laboratoires Boiron – Romania Representative has been sanctioned for the distribution of an unapproved advertising material for the COCCULINE – homeopathic tablets medicinal product. |
| 14.06.2010 | NOVARTIS CONSUMER HEALTH GMBH – Romania Representative has been sanctioned for the distribution of an advertising material different from the one approved by NAMMD for LAMISIL DERMGEL 1% gel medicinal product. |
| 27.05.2010 | MCNEIL PRODUCTS LIMITED C/O JOHNSON&JOHNSON – GREAT BRITAIN has been sanctioned for the broadcast of a TV advertising spot for the Ben-Gay medicinal product without an approval released by NAMMD |