Notifications and penalties advertising
|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.|
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 firstname.lastname@example.org until the date of 08.04.2011.
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 …
|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.|
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.|
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|