17/09/2021
A structured legal guide to marketing, manufacturing, packaging & labelling and advertising in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview. 2. What is the authorization…
08/09/2021
All about marketing, manufacturing, packaging and labeling and advertising of drugs in Portugal. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? (i) Medicinal products The marketing of any medicinal products, including new drugs, biologics and over-the counter medicinal products,…
30/08/2021
A brief overview of the situation regarding marketing, manufacturing, packaging & labeling and advertising within Chinese pharma. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Questions 3 & 6 of the…
23/07/2021
Key legal info on marketing, manufacturing, packaging & labeling, advertising in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? DRUGS The following authorization procedures are available in the Czech Republic for obtaining market authorization…
10/07/2021
Learn more about marketing, manufacturing, packaging & labeling, and advertising in Russian pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications has been already covered by…
26/04/2021
The key facts about marketing, manufacturing, packaging & labeling, advertising in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under the Pharmaceutical Law, all applications for marketing authorization must be made through the Ministry of Health (MOH). The authorization…
20/04/2021
All about marketing, manufacturing, packaging & labeling, advertising in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? a) Medicinal products Chapter 2 of the Pharmaceutical Law sets forth the rules relating to the marketing of…
30/05/2020
The key facts about marketing, manufacturing, packaging & labeling, advertising in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? PHARMACEUTICAL PRODUCTS Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern…
29/05/2020
Key legal info on marketing, manufacturing, packaging & labeling, advertising in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To request the authorization of a clinical protocol of a Pharmaceutical Specialty, the…
28/05/2020
Marketing, manufacturing, packaging & labeling, advertising in Swiss Pharma – an overview. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Medicinal products According to the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act; TPA)…
27/05/2020
All about marketing, manufacturing, packaging & labeling, advertising in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? See Regulatory, Pricing and Reimbursement Overview, question 3. 2. What is the authorization process for the marketing…
04/02/2020
Marketing, manufacturing, packaging & labeling, advertising in Zimbabwe – an overview. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The process is set out in the Medicines Control Authority of Zimbabwe (Guidelines on Submission of Documentation…
03/02/2020
All about marketing, manufacturing, packaging & labeling, advertising in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? See Question 1 of Regulatory, Pricing and Reimbursement Overview. 2. What is the authorization process for…
23/01/2020
All about marketing, manufacturing, packaging & labeling, advertising in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? a. Medicinal Products As a general rule, medicinal products may only be placed on the market once authorization has been granted…
22/01/2020
All about marketing, manufacturing, packaging & labeling, advertising in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? First of all, the medicines must be the subject of clinical trials. These clinical trials must be submitted to the FAMHP and an…
19/01/2020
Marketing, manufacturing, packaging & labeling, advertising in Algerian Pharma – an overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To obtain market authorization for new drugs, biologics and medical devices in Algeria, submission of application to…
11/11/2019
An insight into marketing, manufacturing, packaging & labeling, advertising in United Kingdom. Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorisation process is discussed in the answer to Questions 2 and 3 in Regulatory, Pricing and…
09/11/2019
The key facts about marketing, manufacturing, packaging & labeling, advertising in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Pharmaceutical Products The authorization processes for the marketing of new drugs, biologics, over-the-counter medications, and other medicinal products…
06/11/2019
The legal framework for marketing, manufacturing, packaging & labeling, advertising in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? NAFDAC is the body responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use…
08/10/2019
All about marketing, manufacturing, packaging & labeling, advertising in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Although it is common for the marketing authorisation of medicines and devices to vest in the PRH, this is not necessarily…
23/08/2019
Marketing, manufacturing, packaging & labeling, advertising in Bulgaria – a comprehensive legal overview. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What is the authorisation process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Homeopathic and traditional herbal medicinal products may be placed on the market in Bulgaria based on а registration certificate. All other medicinal products may be placed…
09/08/2019
Marketing, manufacturing, packaging & labeling, advertising in Japanese Pharma – a comprehensive legal overview. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To obtain marketing authorization for new drugs, biologics and medical devices, submission of application to PMDA is…
18/07/2019
All about marketing, manufacturing, packaging & labeling, advertising in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The AEMPS is the authority in charge of granting marketing authorizations in Spain, whether they result from…
17/07/2019
A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please see Question 3 of Regulatory, Pricing and Reimbursement Overview. 2. What is the authorization…
02/07/2019
The key facts about marketing, manufacturing, packaging & labeling, advertising in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Have a distributor authorized by the Ministry of Health that has a valid health license. Grant power to a…
A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? MEDICINAL PRODUCTS In the Slovak Republic, the following authorization procedures are available in order to obtain the…
30/06/2019
Marketing, manufacturing, packaging & labeling, advertising in Romanian Pharma – a comprehensive legal overview. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization,…
An insight into marketing, manufacturing, packaging & labeling, advertising in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? To obtain authorization to develop and market a product, each product must obtain a sanitary registration before the Ministry of Health.…
29/06/2019
An intro to the legal situation for marketing, manufacturing, packaging & labeling, and advertising in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to question 3 in Chapter 1. 2. What is the authorization process for the marketing…
The ins and outs of marketing, manufacturing, packaging & labeling, and advertising in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? Drugs Any marketing of drugs (including biologics and over the counter medications) within Indonesian territory require…
28/06/2019
All about marketing, manufacturing, packaging & labeling, and advertising in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? 1. The Third Chapter of the Medicinal Products Act sets forth the rules relating to the manufacture…
All legal aspects surrounding marketing, manufacturing, packaging & labeling, and advertising in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? The authorization process of marketing new drugs and any medicinal products are as follows:…
27/06/2019
An insight into marketing, manufacturing, packaging & labeling, and advertising in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? B) MEDICINAL PRODUCTS Only those medicinal products having a marketing authorisation granted by the Agency for Medicinal Products…
26/06/2019
The key facts about marketing, manufacturing, packaging & labeling, and advertising in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview, question 3. 2. What is the authorization…
18/06/2019
It is not a secret anymore, many in the industry now know that Health Canada is working on a new version of the policy entitled: The Distinction Between Advertising and Other Activities, dated more than 20 years ago. Earlier this week, Health Canada provided some insights about the reformed policy and offered target timelines for publication and entry into force. The new Distinction Policy should be published in a draft format before the end of this month, in late…
17/04/2019
Joana Silveira Botelho of Cuatrecasas argues for the need for an EU-wide regulatory update on the advertising of pharmaceutical products online, given current rules do not take into account the spread and influence of social media today. Today’s internet is so much more than a company’s website It is undeniable that the internet has changed the world. It is also undeniable how little laws have changed to accommodate the internet and the new reality that emerged from its foundation.…
01/03/2019
Everything you need to know about the marketing, manufacturing, packaging, labeling and advertising of pharmaceuticals in Singapore. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? THERAPEUTIC PRODUCTS For therapeutic products, marketing approval may be obtained by making an application to the Health Sciences…
15/02/2019
All about marketing, manufacturing, packaging & labeling and advertising in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Medicinal Products In line with EU legislation, four different procedures may alternatively be followed in view of obtaining marketing authorization…
12/02/2019
All you need to know about Marketing, Manufacturing, Packaging & Labeling, Advertising in Bolivian pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The first step in order to obtain the corresponding authorization to commercialize products in Bolivia is to…
08/02/2019
The key info on marketing, manufacturing, packaging & labeling and advertising pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Any new drug, biologic, medical device, over the counter medication and in general medicinal product require a Sanitary Registration.…
28/01/2019
The ins and outs of the marketing, manufacturing, packaging & labeling, and advertising in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal…
23/01/2019
Everything you need to know about the marketing, manufacturing, packaging & labeling and advertising of pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The company should be licensed before ANVISA (at the…
08/11/2018
Introducing the legal situation around marketing, manufacturing, packaging & labelling and advertising of pharmaceuticals in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Possible authorization procedures for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and…
Tackling the big issues around marketing, manufacturing, packaging & labelling, and advertising in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Question 3 in Regulatory, Pricing and Reimbursement overview. 2. What is the…
07/11/2018
All legal aspects of marketing, manufacturing, packaging, labeling and advertising of drugs in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? A. MEDICINES (new medicines, biologics, OTC medicines) There are the following ways to obtain marketing authorization for…
06/11/2018
All about marketing, manufacturing, packaging & labeling and advertising in Uruguayan pharma. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview. 2. What is the authorization process for the marketing…
Hot-button legal issues around marketing, manufacturing, packaging & labelling and advertising in Turkish pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under Turkish laws and regulations, a registration process is required for a drug, biologic medicinal product, over-the-counter medications…
26/10/2018
Key info on marketing, manufacturing, packaging and labeling and advertising in Ukrainian pharma. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? With respect to the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and…
12/10/2018
All legal aspects of marketing, manufacturing, packaging, labeling and advertising of drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? MARKETING OF MEDICINES AND MEDICAL DEVICES OR IVDS: Marketing of medicines are regulated by Section…
11/10/2018
An essential legal guide to marketing, manufacturing, packaging & labelling and advertising in Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? For information of the marketing authorization process for new drugs, investigational new drugs, investigational…
29/08/2018
Legal info on marketing, manufacturing, packaging & labelling in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, OTC and other medicinal products is through a marketing…
09/08/2018
Outlining the legal situation for marketing, manufacturing, packaging & labelling in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? See answers to Questions 2 and 3 in Regulatory, Reimbursement and Pricing Overview. 2. What is…
25/10/2016
Key legal info on marketing, manufacturing, packaging & labeling, advertising in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are…
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