Marketing, Manufacturing, Packaging & Labelling, Advertising
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 other medicinal products are described in the answer to question 3 in the Regulatory, Pricing, and Reimbursement Overview.
2. What is the authorization process for the marketing of generic versions of these products?
As for all medicines, generic versions of medicinal products must obtain a marketing authorization before they can be marketed. In order to receive the marketing authorization for generic versions of medicinal products in Lithuania, the applicants have to submit to the SMCA an application together with information and documents required by laws. Marketing authorizations are granted after the SMCA has conducted a scientific evaluation of the medicine’s efficacy, safety, and quality.
When authorizing generic versions of products, the applicants have to prove that their products are bioequivalent to the reference medicinal product. Since information on the safety and efficacy of an active substance(s) is already available from the reference medicine, the applicants usually do not need to provide the results of clinical testing if the applicant proves that the generic medicine is the medicine that is developed to be the same as the medicine that has already been authorised in any country of the EEA.
An applicant can only receive the marketing authorization for generic versions of medicinal products once the period of data exclusivity on the reference medicine has expired. This is usually 10 years from the date of the first authorization.
3. What are the typical fees for marketing approval?
The typical fees for marketing approval are described in the answer to question 4 in the Regulatory, Pricing, and Reimbursement Overview.
4. What is the period of authorization and the renewal process?
The maximum term for the SMCA to evaluate documents of a medicinal product during the authorization process is 210 days from the day when the application with all the required documentation has been submitted.
A marketing authorization is issued for the initial 5-year period. The period for renewal is described in the answer to question 5 in the Regulatory, Pricing, and Reimbursement Overview.
5. What are the requirements, if any, for post-approval pharmacovigilance?
With respect to obligations related to post-approval pharmacovigilance, marketing authorization holders are obliged to:
- establish a pharmacovigilance system which would ensure the execution of pharmacovigilance tasks of the authorization holder;
- submit information on adverse reactions of medicinal products to EudraVigilance;
- register information on adverse effects of medicinal products.
Pharmaceutical and healthcare specialists, healthcare institutions, state institutions, and legal entities carrying out pharmaceutical activities are obliged to inform the SMCA about adverse effects of medicinal products.
The SMCA is obliged to:
- register information on adverse effects of medicinal products received from patients, pharmaceutical and healthcare specialists, healthcare institutions, state institutions, and legal entities carrying out pharmaceutical activities;
- submit information on adverse effects to EudraVigilance.
6. Are foreign marketing authorizations recognized?
Generally, foreign marketing authorizations (i.e. authorizations granted by EEA and/or third countries) are not per se valid in Lithuania. They need to be recognized in Lithuania in accordance with the mutual recognition procedure or decentralized procedure (as described in the answer to question 3 in the Regulatory, Pricing, and Reimbursement Overview).
However, if the medicinal product is authorized via the centralized authorization procedure of the EU (by submitting a single marketing-authorization application to the European Medicines Agency (EMA)), such marketing authorization is recognized both in Lithuania and in other EEA countries.
7. Are parallel imports of medicines or devices allowed?
Yes, parallel imports of medicines and medical devices are allowed subject to certain requirements established by laws.
Medicinal products may be parallelly imported if both of the following conditions are met:
- a medicinal product is registered in the List of Parallelly Imported Medicinal Products;
- a permit for the parallel import of a medicinal product is issued by the SMCA.
A permit for parallel import may be issued in respect of a medicinal product which is identical to the medicinal product already registered in the Republic of Lithuania or sufficiently resembling it. A medicinal product can be held sufficiently resembling another medicinal product if it meets the following criteria:
- the same active substance and the same salt of the active substance, the same ester, ether, isomer or mixtures of isomers, complexes or derivatives of an active substance of isomers;
- the same strength;
- the same pharmaceutical form and administration method;
- the same clinical and pharmaceutical properties.
In order to parallelly import a medical device in Lithuania, it must be marked with a CE mark and an entity willing to import such a medical device has to inform the SHCAA in advance.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
In Lithuania, it is prohibited to bribe healthcare specialists, as well as for healthcare specialists to accept bribes. This also means that gifts, irrespectively of their value, cannot be transferred to healthcare specialists.
Promotional events and scientific congresses held for healthcare specialists are subject to the following restrictions:
- at promotional events of medicinal products, hospitality must not put the main purpose of such an event in the shade and must not extend to others than the participating healthcare specialists. Hospitality in the form of payment of travelling, accommodation and other expenses of healthcare specialists participating in a promotional event is prohibited;
- at professional/scientific congresses, hospitality may only be the secondary purpose of the congress. In congresses, hospitality may be provided or offered only in the form of payment of travelling, accommodation, catering and/or registration expenses of healthcare professionals and/or pharmaceutical specialists.
It is important to mention that visits by medical sale representatives to healthcare institutions with an intent to promote medicinal products to healthcare specialists qualified to prescribe medicinal products are subject to limitations. Medical sale representatives may visit healthcare institutions with an intention to promote medicinal products to healthcare specialists only:
- during the official promotional events organized according to the regulations established by the head of the healthcare institution; (or)
- after the end of healthcare specialists’ official patient admission time.
The expenses incurred by pharmaceutical companies for promotional and professional events must be declared to the SMCA and disclosed to the public.
The pharmaceutical companies in Lithuania are also bound by the Code of Ethics for Pharmaceutical Marketing, adopted by the Innovative Pharmaceutical Industry Association which is a member of the European Federation of Pharmaceutical Industries and Associations and of the Medicines Manufacturers Association. The Code of Ethics for Pharmaceutical Marketing also establishes specific restrictions in relation to marketing of medicinal products, e.g. limitations related to: donations and grants to institutions; frequency, timing, and duration of visits aiming to meet healthcare professionals or to healthcare facilities; samples of medicinal products, etc.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The main authority issuing the regulations re manufacturing of both medicinal products and medical devices is the Ministry of Health.
The requirements for a manufacturing approval are set out mainly in the Law of the Republic of Lithuania on Pharmacy and its regulations on good manufacturing practices (GMP), as well as the EU Guidelines for good manufacturing practices for medicinal products for human and veterinary use (Volume 4). These legal acts regulate and provide guidelines and specific requirements related to the manufacturing of medicines, e.g., requirements for:
- personnel of the manufacturer;
- facility and equipment;
- manufacturing and quality controls;
- packaging and marking;
The requirements for manufacturing medical devices are set out mainly in the Law on of the Republic of Lithuania the Health System and its regulations, as well as the European Commission’s guidelines. Legislation provides the following requirements for the manufacturing of medicines, e.g., requirements for:
- facility and equipment;
- enforcement of quality control;
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
Lithuanian manufacturing requirements for medicines are part of GMPs defined by the European Commission.
Lithuanian GMPs compatibility with FDA requirements is described in the answer to question 8 in the Regulatory, Pricing, and Reimbursement Overview.
11. What is the inspection regime for manufacturing facilities?
The SMCA is empowered to make inspections of premises of manufacturers of medicinal products.
The SHCAA is empowered to make inspections of premises of manufacturers of medical devices.
In case of non-compliance, institutions may impose sanctions on manufacturers which may vary from fines (from EUR 30 up to EUR 3,000) to a possible withdrawal of the issued permissions (licences).
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
No, national competent authorities are responsible for inspecting manufacturing sites located within their territories in the EU.
A national competent authority may carry out inspections with respect to products on behalf of the EMA under the centralized marketing-authorization procedure.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The storage and handling of medicines in the wholesale distribution phase must be performed in accordance with the EU Commission Guidelines on Good Distribution Practice of medicinal products for human use. The Guidelines establish certain requirements for the transportation and storage of medicines, e.g.:
- wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products;
- premises should be clean, dry and maintained within acceptable temperature limits;
According to the Guidelines on Good Pharmacy Practice, the medicinal products must be generally handled and stored in accordance with the storage conditions specified by the manufacturers. There are also specific requirements applied to the storage of medicinal products in pharmacies, e.g.
- premises for the storage of medicinal products must be installed and operated in such a way as to guarantee the quality and safety of medicinal products;
- medicinal products must be stored separately from the expired medicinal products or products with the damaged packaging;
- no unused equipment, no food products or personal items of the staff should be stored in the same storage as the medicinal products;
- medicinal products must be stored in the packaging of the manufacturer or in a package modified in accordance with the procedure laid down by laws;
Medical devices must be handled and stored under the conditions provided by their manufacturer. If the manufacturer does not provide specific conditions for the handling and storage of medical devices, they must be handled and stored in such a way as not to compromise their safety.
14. What information must be included in medicine and device labelling?
Labelling of medicinal products must comply with the requirements established in the Law of the Republic of Lithuania on Pharmacy and its regulations and must contain the certain information required by laws, e.g.:
- a distinctive brand name;
- a pharmaceutical form, drug concentration; a formulation, formula description, dose;
- conservation and storage information;
- precaution and warning legends, including the requirement to store the product out of reach of children;
- authorization holder’s information, including address;
All medical devices must be accompanied by instructions for use. The instructions for use may not be included in Class I or Class II medical devices if the medical device can be safely used without such instructions. The information provided by the manufacturer on the label and in the instructions for use must be in Lithuanian.
As for the packaging of medical devices, the information on the manufacturer and its address as well as information which allows patients and healthcare specialists to distinguish the medical device, its serial number, CE marking have to be provided.
15. What additional information may be included in labelling and packaging?
The labelling and packaging of both medicinal products and medical devices additionally may contain symbols or pictograms explaining the provided mandatory information. This information cannot contain ads.
As for additional text information, if all required information in the Lithuanian language is included, the same information translated into other languages may be included as well.
16. What items may not be included in labelling and packaging?
Generally, the labelling and packaging of medicinal products and medical devices may not include certain information, e.g.:
- misleading information;
- information which is contrary to good morals;
- information not related to the medicinal product or medical device,
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
MEDICINAL PRODUCTS AND MEDICAL DEVICES
The marketing and advertising of medicinal products and medical devices must satisfy the following general requirements related to advertising:
- the advertisement cannot be misleading;
- the sound and text of the advertisement must be presented in the Lithuanian language;
- the advertisement must be clearly identifiable. Hidden advertising is prohibited. In cases where certain information may not be unambiguously identified as advertisement, such advertisement must be marked with the word ‘advertisement’;
- the advertisement cannot infringe persons’ data protection rights;
- the advertisement cannot infringe third parties’ intellectual property rights;
In addition to the general requirements indicated above, advertisement of medicinal products is subject to special requirements, e.g.:
- non-reimbursable non-prescription medicinal products can only be advertised for the general public;
- it is prohibited to perform such marketing actions which would endorse measureless consumption of medicinal products, for instance, ‘buy one, get one free’, etc.;
- for healthcare professionals, medicinal products can only be advertised in special sources not accessible to the general public (e.g., websites, articles, journals);
- medicinal products can only be advertised on media sources, this means that advertisement of medicinal products on pens, notes, clocks, calendars, etc. is prohibited.
Also, additional rules on the advertising of medicinal products are established by the Code of Ethics for Pharmaceutical Marketing, adopted by the Innovative Pharmaceutical Industry Association which is a member of the European Federation of Pharmaceutical Industries and Associations and of the Medicines Manufacturers Association. For example, the Code of Ethics for Pharmaceutical Marketing provides that promotion of medicinal products must be accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned; promotion must encourage the rational use of medicinal products; it also provides additional requirements related to transparency of promotion, distribution of promotion, use of quotations, etc.
In the advertisement of medical devices, no patient’s name, image, recommendations of health care institutions, health care professionals or their professional associations can be used.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
All types of medicines can be sold in licensed pharmacies. Only homeopathic, herbal, and over-the-counter (OTC) non-reimbursable medicinal products can be sold in online pharmacies.
However, there are legislative initiatives currently in process for:
- allowing the sale of prescription medicinal products online;
- allowing the sale of OTC medicinal products in retail shops, filling stations, etc.
Medical devices can be sold only in their trading places, vending machines, healthcare institutions, and through e-shops.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
Requirements for the marketing and advertising of medicinal products and medical devices via e-mail, by Internet, social media, etc., are described below.
It is important to note that advertising of certain medicinal products (e.g., prescription or reimbursable medicines) to healthcare professionals may be performed only through publications and websites approved by the SMCA. Access to these sources must be limited to healthcare professionals only.
20. May medicines and devices be advertised or sold directly to consumers?
Only non-prescription homeopathic, herbal, and OTC medicines and medical devices can be advertised directly to consumers. For more details in relation to requirements and limitations on the advertising of medicinal products and medical devices, please see below.
Medicines and medical devices may be sold directly to consumers subject to certain limitations. For more information on the sale of medicines and medical devices, please see below.
21. How is compliance monitored?
The SMCA strictly monitors and evaluates advertisement of medicinal products, except of misleading advertisement which is a prerogative of the Competition Council of the Republic of Lithuania.
Monitoring of advertising activities for medical devices is performed by the State Consumer Rights Protection Authority and, in case of misleading advertising, by the Competition Council of the Republic of Lithuania.
22. What are the potential penalties for noncompliance?
The sanctions for non-compliance in case of advertising of medicinal products are:
- a fine ranging from EUR 500 up to EUR 3,000 (this sanction may be imposed by the SMCA);
- a fine ranging from EUR 289 up to EUR 34,754 (this sanction may be imposed by the Competition Council of the Republic of Lithuania);
- suspension/prohibition of dissemination of advertisements (this sanction may be imposed by the SMCA or the Competition Council of the Republic of Lithuania);
- compelling the advertiser to deny wrongful propositions (this sanction may be imposed by the SMCA).
As regards the non-compliance with the requirements for advertising of medical devices, sanctions are:
- a fine ranging from EUR 289 up to EUR 34,754 (this sanction may be imposed by the Competition Council of the Republic of Lithuania or the State Consumer Rights Protection Authority);
- a fine ranging from EUR 140 up to EUR 560 (this sanction may be imposed by the State Consumer Rights Protection Authority);
- suspension/prohibition of dissemination of advertisements (this sanction may be imposed by the Competition Council of the Republic of Lithuania or the State Consumer Rights Protection Authority).