Dicle Dogan is an associate in the Intellectual Property Department, Life Sciences Practice Group and Advertisement and Media Law Practice Group under the Regulated Markets Department and in the Corporate and Commercial Department of Mehmet Gun & Partners. Ms. Dogan provides consultancy to corporations and associations within the life sciences sector on regulatory compliance. Her litigation work centres on the intellectual property field particularly on trademark infringement and unfair competition.
In Life Sciences Practice Group, she has been representing multinational life sciences companies including manufacturers of pharmaceuticals, biotechnology, medical device, special food and feed, cosmetics and other consumer products and providing companies with consultancy for their day-to-day business activities. This includes sales and supplies of goods and services, promotional practices, pricing regulations, reimbursement regulations, marketing authorization and permission procedures, clinical trials and non-interventional studies in cooperation with relevant practice groups throughout the firm.
With regards to Advertisement and Media Law practice, she has been mainly involved in legal clearances of advertisements, promotional campaigns, product labelling and packaging issues as well as privacy and data protection issues.
She has graduated from Lycée Français Jean-Monnet, Brussels in 2005 and Galatasaray University, Faculty of Law, Istanbul in 2010.
Recent changes to the Regulation on the Sale, Advertisement and Promotion of Medical Devices introduced a sponsorship exemption for training activities held in medical device simulation centres and cadaver centres for surgical training, which are no longer categorised as scientific or educational meetings. However, no clear definition of what constitutes a 'medical device simulation centre' or 'cadaver centre for surgical training' has been provided.
Recent amendments to the Guidelines on the Supply from Abroad and the Use of Pharmaceuticals have changed the practice of the Named Patient Programme (NPP) in Turkey. Supplying non-approved or unavailable pharmaceutical products from abroad is an exceptional route under the NPP. However, increased regulatory and price pressures have resulted in more products becoming unavailable on the Turkish market.
The new Regulation on the Promotional Activities of Pharmaceutical Products for Human Use was recently published. The regulation contains new provisions relating to the disclosure obligations of marketing authorisation holders and other frequently debated matters, including co-promotion, the promotion of pharmaceuticals imported on a patient basis and financial support for conferences.
The Pharmaceutical and Medical Device Institution recently published new Guidelines on the Supply from Abroad and the Use of Pharmaceuticals. The purpose of the guidelines is to determine the procedures regarding the supply of pharmaceuticals from abroad that have no marketing authorisation in Turkey or that have marketing authorisation but are not available on the Turkish market for various reasons.
The long-awaited Regulation on the Sale, Advertisement and Promotion of Medical Devices, which bans the advertisement to the public of some categories of medical device, is now in force. The regulation introduces provisions relating to the sale, advertisement and promotion of medical devices, promotional activities for medical devices and the real or legal persons engaged in these activities.
New guidelines were published in mid-2013 that introduce new training and certification requirements for medical sales representatives, with representatives now expected to take an examination. Those who do not pass the examination will no longer be able to practice. Employers may therefore be obliged to make some of their employees redundant in order to comply with the law.
A new regulation regarding products that are offered for sale with health claims recently entered into force. The duties of the Pharmaceutical and Medical Device Institution have been extended in order to fulfil the regulation's objectives. The new regulation will bring a more detailed level of awareness in relation to the correct use of health claims, as well as suitable protection for consumers.
The Ministry of Food, Agriculture and Livestock recently published the Food Codex Energy Drinks Communique 2017/4 in the Official Gazette. The communique introduces significant amendments to the market supply, advertising, labelling and sale of energy drinks, the most important of which prohibits the sale of energy drinks to individuals under the age of 18. Business operators must comply with the new communique no later than December 31 2017.