Marketing, Manufacturing, Packaging & Labeling, Advertising
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 of medicinal products (including new drugs, biologics, over-the-counter medications and medicinal products in general), particularly the manufacturing authorisation and its limits in §§ 13 and 15, the process leading up to the decision on the manufacturing authorisation in § 14, the required expert knowledge in § 15, relevant deadlines in § 17, the withdrawal, revocation and suspension processes, the areas of responsibility in § 19, Notification obligations in § 20, a definition of the active substances and other substances governed by these rules in § 20a, special provisions on the sourcing of tissues and tissue preparations, pertinent laboratory testing, processing, perservation, storage and placing in the market in §§ 20b and 20c, as well as certain exceptions from these tissue-related rules.
2. Concerning medical devices, the corresponding rules of the Medical Devices Act apply.
2. What is the authorization process for the marketing of generic versions of these products?
Generic versions of medicinal products and medical devices are subject to essentially the same authorization rules, except that certain exemptions may apply regarding the submission of documentation.
3. What are the typical fees for marketing approval?
See the information provided to Question 4 of Regulatory, Pricing, and Reimbursement.
4. What is the period of authorization and the renewal process?
1. See Question 5 above: Pursuant § 31 of the German Medicinal Products Act, the marketing authorisation expires (i) if the authorised medicinal product is not placed on the market within three years from marketing authorisation, or if it was placed on the market, the market presence is interrupted for three successive years; (ii) when waived in writing; (iii) five years after it was granted, unless a timely application for prolongation is filed nine months prior to the expiry date; (iv) if the prolongation of the marketing authorisation is refused. Prolonged marketing authorizations are valid for an unspecified period, subject to detailed conditions.
2. Pusuant § 31 (2) of the German Medicinal Products Act, the application for prolongation shall be supplemented by a report giving details of whether, and to what extent, the criteria by which the medicinal product is assessed have altered over the previous five years. Updates of the quality, safety and efficacy documents must be filed.
Further details apply as set forth in § 31 of the German Medicinal Products Act.
5. What are the requirements, if any, for postapproval pharmacovigilance?
1. Pharmacovigilance is aiming at drug safety and involves the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
The legal framework of pharmacovigilance is set forth in the Thenth Chapter of the Medicinal Products Act, comprising the organisation of the pharmacovigilance system (§§ 62 to 63a), the pharmacovigilance obligations of the marketing authorisation holder (§ 63b), involving documentation and reporting obligations (§§ 63c and 63 i), periodic safety update reports (§ 63 d), prerequisites for non-interventional post-authorisation safety studies (§§ 63f and 63g).
2. All events of pharmacovigilance are centrally recorded and evaluated, in particularly any adverse reactions, interactions with other products, adulterations as well as potential risks to the environment, all in in co-operation with the agencies of the World Health Organization, the European Medicines Agency, the medicinal product authorities of other countries, the health and veterinary authorities of the federal Laender, the medicinal product commissions of the chambers of the health professions and national pharmacovigilance centres. The competent authority monitors the outcome of the risk minimisation measures contained in risk management plans and evaluates the data in the EudraVigilance database. It can inspect the collection and evaluation of medicinal product risks and the co-ordination of necessary measures in enterprises and facilities that manufacture, place on the market or clinically test medicinal products. To this end, the representatives of the competent authorities can enter the production areas and business premises during regular working hours, inspect documents including the pharmacovigilance master file and request information.
If an inspection results in the conclusion that the marketing authorisation holder fails to meet the requirements of the pharmacovigilance system, the authority shall notify the marketing authorisation holder of the detected deficiencies and notify other authorities involved.
3. Pharmaceutical entrepreneurs must appoint a graduated plan officer which is a qualified person who is resident in a Member State of the European Union having the required expert knowledge and the reliability necessary for exercising the assigned function of setting up and managing a pharmacovigilance system and to collect and evaluate notifications on medicinal product risks. The graduated plan officer is responsible to meet all notification and risks response requirmements.
4. The marketing authorisation holder is obligated to set up, operate and update, for every medicinal product, the prescribed pharmacovigilance system in order to scientifically evaluate all information on risks, examine risk minimisation and prevention measures and, if necessary, take risk minimisation and prevention measures immediately. To that end it must maintain and disclose when requested the pharmacovigilance master file. Pharmacovigilance information may not be published unless the competent German authority, the European Medicines Agency and the European Commission have first been notified in accordance with the prescribed procedures.
Other statutory duties and obligations apply as set forth in the Thenth Chapter of the Medicinal Products Act and supplementing provisions.
These rules do not apply to medicinal products that are used as investigational medicinal products within the framework of a clinical trial.
6. Are foreign marketing authorizations recognized?
Yes, subject to EMA and German regulations.
7. Are parallel imports of medicines or devices allowed?
Yes, subject to German and EMA import regulations.
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?
1. The marketing practices for medicinal products and medical devices are governed by (i) the Health Advertsing Law (Gesetz über die Werbung auf dem Gebiete des Heilwesens (Heilmittelwerbegesetz – HWG) of 11 July1965, most recent amendment of 20 December 2016) and (ii) the Act Against Unfair Trade Practices in the versions of 3 March 2010, as last amended on 17 February 2016 (http://www.gesetze-im-internet.de/englisch_uwg/englisch_uwg.html), as well as a number of Codes of Conduct which are regularly applied by the courts as generally applicable rules of trade practice. For further details see answers to Question 38 below.
2. By way of general background regarding sweepstakes incentives, the following principal rules apply:
Subject to restrictions set forth in the Health Advertising Law, random draw promotions, instant win games are permissible provided the entrant is not required to pay a stake. There is no bonding, prize deposit or license required for promotional chance or skill based games or contests. No purchase is required. Restrictions of German and any other applicable (EU) data protection laws apply.
3. Unless the entrant (data subject) has expressly consented to the use of its personal data (or unless that consent is implied as part of the legal relationship entered under the Official Rules), personal data may not be collected, processed or used. Data transfer to a jurisdiction outside the European data protection regime requires special consent. The EU Commission has adopted in 2016 its decision on the EU / U.S. Privacy Shield which protects the fundamental rights of individuals in the EU whose personal data is transferred to the United States. It regulates transatlantic data transfers.
4. If a promotion is directed to German entrants, foreign sweepstakes sponsor should have the official sweepstakes rules reviewed in respect of compulsory German local law. Sponsors should be aware that the enforcement of German fair trade laws is mainly a matter of enforcement by competitors or trade associations by means of cease and desist requests and complaints to the courts (including quick and effective preliminary injunction proceedings). Government agencies or regulatory bodies get rarely involved.
See question 17 below for enforcement rules.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
1. The Eighth Chapter of the Medicinal Products Act governs safety and control measures by means of regulations for enterprises and facilities which develop, manufacture, test, store, package or place on the market medicinal products.
This applies to active substances and other substances as well as tissues intended for the manufacture of medicinal products. The regulations govern the development, manufacture, testing, storage, packaging, quality assurance, acquisition, supply, stockpiling and marketing of medicinal products, the maintaining and keeping of records on the operational processes, the keeping and monitoring of the animals used in the manufacture and testing of medicinal products and the records kept on them, staffing requirements, the nature, size and equipment of the premises, sanitation requirements, the nature of containers and other packaging, the labelling of containers and packaging in which medicinal products and their starting materials are stored, the stand-by obligation for medicinal product wholesalers, the retention of batch samples including quantities and duration of storage, the labelling, separation or destruction of medicinal products which are unfit for marketing etc.
2. The framework is laid down in the “Pharmacopoeia“ which is a collection of recognized pharmaceutical rules regarding the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture as developed by the German Pharmacopoeia Commission (set up at the Federal Institute for Drugs and Medical Devices) or by the European Pharmacopoeia Commission. It is published by the Federal Institute for Drugs and Medical Devices in co-ordination with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food Safety.
The Pharmacopoeia also contains requirements regarding the nature of containers and outer packaging.
In a nutshell, only substances and packaging (containers) coming into contact with a medicinal product, and only the pharmaceutical forms compliant with recognised pharmaceutical rules, may be used in the manufacture of medicinal products. There is an official compilation of test procedures for the sampling and testing of medicinal products and their starting materials.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
The answer is generally yes, subject to specific requirements of German law.
11. What is the inspection regime for manufacturing facilities?
The compentent authorities can inspect manufacturing enterprises and facilities marketing or clinically testing medicinal products. To this end, the authorities can enter the production areas and business premises during regular working hours, inspect documents including the pharmacovigilance master file and request information.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes, by means of judicial and administrative assistance procedures and subject to co-ordination with the relevant German authorities.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
There is a general duty to affix on the outside of the packaging the full name and postal address (not the PO Box) of the manufacturer or the importer. Certain exceptions apply, see also the details provided in response to question35 below.
Packaging misleading anyone as to the size, content or quality of the product is prohibited.
There are also many rules regulating certain mandatory disclosures and indications, including the language to be used, which must be affixed to the packaging, depending on the type of the product (see question 14 below).
14. What information must be included in medicine and device labeling?
1. § 10 of the Medicinal Products Act governs essentially all labelling requirements regarding medicinal products. Finished medicinal products not intended for clinical trials or exempted from marketing authorisation requirements must be labelled with (i) the name and address of the manufacturer and local representative if appointed, (ii) the name of the medicinal product, (iii) details of the strength and pharmaceutical form, (iv) any applicable information regarding administration to babies, children or adults, (v) if the medicinal product contains up to three active substances, the international non-proprietary name (INN) or, if the latter does not exist, the common non-proprietary name, (vi) the marketing authorisation number (vii) the batch identification or (if not distributed by batch) the date of manufacture, (viii) pharmaceutical form, (iix) the content by weight, volume or number of items, (ix) the method of administration, (x) the active substances by type and quantity and other constituents by type as required by the market authorization, (xi) in the case of genetic engineering, the active substance and the name of the genetically modified micro-organism or cell line used in its manufacture, (xii) the expiry date with the instruction ‘verwendbar bis’ (to be used by), (xiii) in the case of a prescription drug the indication ‘Verschreibungspflichtig’ (prescription-only), (xiv) in the case of other medicinal products that may only be dispensed to consumers in pharmacies, the indication ‘Apothekenpflichtig’ (pharmacy-only), (xv) in the case of samples, the indication ‘unverkäufliches Muster’ (sample – not for sale), (xvi) the indication that medicinal products are to be kept out of the reach of children (unless they are curative waters), (xvii) where necessary, special precautions for the disposal of unused medicinal products or other special precautions to avoid hazards to the environment, (xviii) the intended use in the case of non-prescription medicinal products. Other requirements apply (such as the name of the medicinal product in Braille language, warnings, specific storage instructions etc).
2. Special rules apply to medical devices in accordance with the Medical Devices Act (Medizinproduktegesetz, MPG) of 2 August 1994, as amended, as well as supplementary laws and regulations governing the marketing of medical devices.
15. What additional information may be included in labeling and packaging?
1. § 11 of the Medicinal Products Act governs the rules applicable to information leaflets to be placed in the package of finished medicinal products (not applicable to products intended for clinical trials, residue testing, or products which do not need a marketing authorisation. The heading oft he leaflet must be ‘Gebrauchsinformation’ (Instructions for Use). It must contain, in the order prescribed by the Act, in easily legible, readily comprehensible German and in conformity with the product information required for members of the medical professions and trade (§ 11a): (i) the name of the medicinal product (§ 10), (ii) the substance or indication group or the mode of action, (iii) the therapeutic indications, (iv) a list of information that must be read before taking the medicinal product, namely contra-indications, corresponding precautions for use, interactions with other medicinal products or other products, warnings, (v) the instructions under normal conditions of use, relating to posology, method of administration, frequency and, if necessary, time of administration, if required, duration of treatment, (vi) warnings in the event of an overdose, forgotten doses or warnings on the risk of adverse consequences if the treatment is stopped, (vii) the specific recommendation that a doctor or pharmacist should be consulted in the event of queries relating to the use, (viii) a description of adverse reactions, counter measures and an additional standard text which explicitly instructs the patient to inform their physicians, pharmacists, health professionals or the competent authority directly of every suspected adverse reaction, (iix) the expiry date stated on the packaging with a warning that the medicinal product may not be used after the expiry date, required special precautions for storage and information on shelf life after opening of the container or after preparation of the ready-to-use preparation by the user, (ix) if required, a warning about specific visible signs indicating that the medicinal product may no longer be used, (x) complete qualitative composition in terms of active substances and other constituents and quantitative composition in terms of the active substances, (xi) the pharmaceutical form and content by weight, volume or number of items for each of the medicinal product’s pharmaceutical forms, (xii) the name and address of the pharmaceutical entrepreneur and, where applicable, of his/her local representative, (xiii) the name and address of the manufacturer or importer who released the finished medicinal product for placing on the market. In case other product names are used in other EU Member States, a list of these other names must be stated, (xv) the date of the most recent revision of the package leaflet.
2. Other information may be required and special rules apply to living organism in the case of virus vaccines, human blood plasma, traditional herbal medicinal products and other products as well as products for animal use. At the request of patient organisations, the package leaflet must be made available in formats appropriate for the blind and and partially-blind persons.
3. Pusuant to § 11a of the Medicinal Products Act, members of the medical profession may ask for instructions for use by experts (expert information) for finished medicinal products which are subject to or exempted from the obligation to obtain a marketing authorisation. The instructions must bear the heading ‘Fachinformation’ (expert information) and must include the information set forth in § 11a of the Act, including but not limited to the name of the medicinal product, followed by the strength and the pharmaceutical use form, information on the qualitative and quantitative composition in terms of active substance and other constituents, knowledge required for proper administration of the product, the pharmaceutical form, clinical information, therapeutic indications, posology and method of administration, contra-indications, special warnings and precautions for use, precautions to be taken by the patient, interaction with other medicinal products or other products if this is likely to influence the effect of the medicinal product, use during pregnancy and lactation, effects on the ability to drive or operate machinery, adverse reactions when used as intended, overdosage symptoms, emergency procedures, antidotes, pharmacological properties, pharmaceutical information, the date of first authorisation or prolongation of the authorisation, the date of revision of the expert information, as well as a certain uniform instruction that explicitly calls upon health professionals to report suspected adverse reactions.
Other provisions: The German Federal Ministry of Health may issue additional regulations.
16. What items may not be included in labeling and packaging?
On or in the package of a medicinal product there may be no advertising (of any product). It is important to make a difference between required product information and prohibited promotional content.
Certain additional product information which is not otherwise governed by a regulation of the European Community or the European Union, or which is already permissible pursuant to such a regulation, shall be permitted if it relates to the use of the medicinal product and is not inconsistent with other required information. Such information must be clearly separate and distinct from the information required in the package information.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
1. By way of general background information, all advertising (print, billboard, radio; broadcast, TV, movie, and online media) is governed by German statutory law, administrative regulations and industry self-regulation. Relevant advertising rules relate to fair trade, consumer protection, distance (electronic) contracting, data protection, privacy, industrial and intellectual property, the antitrust laws, regulations governing audio-visual media services, youth protection as well as regulations concerning particular products and services (such as medicinal products and medical products, food, tobacco, alcohol etc).
2. The primary source of advertising regulation are the German Law Against Unfair Trade Practices of 3 March 2010, last modified 17 February 2016, implementing the EU Unfair Commercial Practices Directive (Directive 2005/29/EC of 11 May 2005), the Privacy and Electronic Communications Directive (Directive 2002/58/EC of 31 July 2002) and the Technical Standards and Regulations Directive (Directive 98/34/EC of 22 June 1998, now replaced by Directive 2015/1535/EU). Other EU sources applicable in Germany are the Regulation No 1924/2006/EC of 20 December 2006 on nutrition and health claims made on foods. Further relevant sources are the Law Relating to the Enforcement of EU Consumer Protection of 21 December 2006 and the Price Declaration Regulation (as revised on 17 July 2017).
3. Procedurally, the German Law Relating to Cease and Desist Claims regarding Consumer Law and Other Violations (as revised 17 July 2017) regulates special issues of unfair advertising prosecution.
4. Health-related advertising (i.e. advertising relating to pharmaceutical/medicinal products (drugs), medical devices and other products where the advertising concerns the diagnosis, cure, relief or abatement of a medical condition of human beings or animals, as well as advertising relating to plastic surgery without medical indication) is regulated by the Health Advertising Law (Heilmittelwerbegesetz) of 19 October 1994, amended most recently on 20 December 2016 (for further details see also answer to question 29 above).
In terms of the Law’s basic rules, health advertising is considered misleading and is prohibited if: (i) the advertised product has not been approved for marketing; (ii) it claims, in particular, an efficacy or effect which does not exist; (iii) it advertises a guaranteed success or the absence of detrimental effects in case of long term use; (iv) it conceals the intent of advertising; (v) it contains untrue or misleading statements regarding the composition or property of a medicinal product, medical device or other product or treatment; or (vi) it contains incorrect information on the identity, education, ability or records of the manufacturer, inventor or related persons.
5. The German Health Advertising Law prescribes legible doctor and patient information (subject to the rules of the Medicinal Products Act described above).
Advertising to the public (as opposed to members or institutions of the medical or veterinarian professions, or parties permitted to trade with relevant products) is restricted and must bear special warnings. Any such advertising may not be directed to children below the age of 14 and may not be connected with promotional contests or sweepstakes promoting excessive use of medicinal products or medical devices. Prescription drugs may not be advertised except to doctors, dentists, veterinarians, pharmacists and persons permitted to trade in such products.
6. The law regulates the extent to which members or institutions of the medical or veterinarian professions, or parties permitted to trade relevant products may be offered, or may accept, a benefit, gift or other promotional item (see the summary of compliance rules in answer to question 29.)
7. German law does not require government pre-approvals of advertising (certain exceptions apply in the sector of youth protection). On a voluntary, self-regulatory basis, the Central Association of the German Advertising Industry (Zentralverband der Deutschen Werbewirtschaft—http://www.zaw.de) offers certain pre-clearance and advisory services to its members. A membership list is available at http://www.zaw.de/index.php?menuid=87.
8. For their own protection against cease and desist claims, advertisers do normally pre-clear advertising (by in-house or external cousel).
In Germany, advertising regulations are not normally enforced by government bodies, but rather by competitors, consumer protection agencies, or industry trade associations, in each case requesting enforcement of applicable German law. These organizations include, for instance, the Centre of Protection against Unfair Competition (Wettbewerbszentrale) in Bad Homburg, or Integritas (the self-regulatory body for pharmaceutical advertising) in Bonn. As concerns drug, medical device and food advertising, product labeling etc, relevant public institutions (agencies and regulatory bodies) monitor the market and enforce fair competition and fair trade rules, as well as regulations pertaining to their specific competencies.
9. To prosecute a violation, a competitor or qualifying consumer or industry association claiming a violation would, as a first step, send a formal cease and desist request to the violating party. The defendant party may either refuse to comply with the request or accept the request by issuing a formal cease and desist undertaking, including a penalty clause stating that any future violations will be subject to a penalty payment. If a cease and desist request is refused, the complaining party may ask a court to issue a cease and desist order by preliminary injunction (even without notice or hearing). A decision on such a motion is normally available in a matter of hours or days. The defendant party may contest the injunction order by a filing an ‘objection’. Any resulting court judgment is subject to appeal to the appellate court.
10. In practice, claimants would not normally pursue claims for damages in unfair advertising cases because the required proof and quantification of damages is generally difficult to establish in court. In theory, it is possible to ask that profits gained through an illegal trade practice should be surrendered to the government. In practice, however, this sanction has little relevance in unfair trade disputes.
11. Apart from administrative sanctions, there are not normally criminal sanctions, except in cases of intentional, fraudulent misleading of the public, for instance in violation of § 16 of the German Law Against Unfair Trade Practices which prohibits misleading advertising.
12. Consumers may indirectly prosecute violations of fair trade laws aiming at the protection of consumers, by asking a qualifying fair trade protection association (see answer to question 8 above) to take appropriate action against the advertiser.
13. Advertising self-regulation is becoming increasingly customary in Germany. The German Advertising Council (Deutscher Werberat—see http://www.werberat.de/keyfacts) and, for instance, pharmaceutical industry organizations operating on a membership basis have gained significant authority (by example, the Association on Self-Regulation in the Pharmaceutical Industry (“FS-Arzneimittelindustrie”, https://www.fsa-pharma.de/ and www.pharma-transparency.eu/).
The German Advertising Council is a founding member of the European Advertising Standards Alliance (EASA), and co-operates closely in this sector with the International Chamber of Commerce (ICC).
14. These bodies create ‘best practice’ rules (codes of conduct) which influence the interpretation of statutory and regulatory law by the courts. All self-regulatory bodies have adopted advertising codes which are often available in the English language.
15. If drug advertisement contains a specific claim relating to the properties or characteristics of an advertised product or service, the advertiser may be required, by relevant statutory or case law, to substantiate such claim. Substantiation requirements are contained in a number of laws and case law relating to specific products and services, particularly health and environmental (green) advertising. Even if there is no specific substantiation requirement, if a competitor, or competent fair trade association, challenges the accuracy of a given claim, the advertiser must prove the accuracy of its claim by substantiation of the alleged facts. This also applies for study results referenced by the advertiser.
16. Endorsements and testimonials must be truthful and may not be misleading. For instance, a testimonial can be misleading if the influencer is not qualified to comment on the endorsed product. In German health advertising law, it is not permitted to advertise, to consumers, an endorsement and testimonial by a persons practicing in the health sector or as an academic if such endorsement or testimonial is likely to increase the use of the advertised drug.
17. The European Directive 97/55/EC dated 6 October 1997 regulating comparative advertising in Europe has been adopted into German fair trade legislation. Comparative advertising is permitted subject to certain restrictions. Comparative advertising is permissible if it concerns products or services serving the same purpose and relates objectively to one or more features of a product or service which are essential relevant verifiable typical for the product or service. Comparative advertising is illegal if it diminishes, in an unfair manner, the reputation of a competitor or unfairly disparages or degrades the products or services of a competitor or its personal or business affairs. As applies to any other advertising, comparative advertising must be true and accurate.
18. Advertising involving the price of a product or service must comply with the Price Declaration Regulation (Preisangabenverordnung). Prices advertised to consumers must include the Value Added Tax (VAT) and any other price components. Special rules apply in distance sales, eg the obligation to disclose additional packaging or mailing charges. Price change conditions are subject to restrictions. Products shown in shops, displayed in shop windows or in catalogues must clearly state the price, either on or near the product. Prices of products sold by weight, volume or size, must be stated with their unit price and their price by a stated standard weight, volume or size.
19. ‘Special Sales’, ‘Off Season Sales’, ‘Below Cost Sales’, ‘Clearances’ or special promotional periods during which goods or services are offered on special terms for a limited period of time are permitted, provided that any offered price reduction is a true price reduction that applies for a considerable period of time (no short-term price swinging). Announcements must not be misleading regarding the original or reduced price. Offers must comply with the Price Declaration Regulation. Conditions for special offers must be clear and unambiguous as to their scope (eg clear indication of any exceptions) and, if limited in time, state the period during which it is applicable. A ‘discount’ is a price reduction offer, an additional quantity of an identical product or service purchased, or a cash value offered by means of a coupon or voucher which can be applied against the purchase price of an identical product or service. Discounts are permissible, but subject to fair trade limitations relating to advertising that is misleading, or exerts undue influence.
20. The full name and address of the online advertiser must be disclosed in all advertising and offers which promote the properties and price of a product or service in a manner which enables the average consumer to make a purchase decision. The mere indication of an internet address is not sufficient.
21. As a rule, advertising content must be separate from editorial content. Advertising must be clearly recognizable as advertising, eg there must be a mark stating that the content is an advertisement. Advertising in an editorial context must be marked ‘advertising’ (‘Anzeige’).
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
1. Medicinal products and devices are sold by pharmacies (Apotheken), drugstores (Drogerien), medical supply stores (Sanitätshäuser) and other stores, depending on the kind of medicinal product and device. The sale of pharmacy-only and prescription medicinal products is restricted to pharmacies.
2. Online purchases and delivery of medicinal products by mail are permitted for pharmacies carrying a special license for “shipping pharmacies”(”Versandapotheken”) pursuant to § 11a Pharmacy Law. The shipping pharmacy sector is subject to the regulations applicable to regular local pharmacies, plus a number of special rules relating to online sales pusuant to the license conditions. Shipping of medicinal products by pharmacies is permitted since 2004 (§ 43, paragraph 1 of the Medicinal Products Act). In Germany, well over 3,000 of the 21,000 pharmacies do have the required medicinal products shipping license as an additional (side) distribution channel of the pharmacy. Licensed shipping pharmacies are listed on the website of the German Institute for Medicinal Information and Documentation (DIMDI) www.dimdi.de, together with additional information on this subject matter.
3. The Seventh Chapter of the Medicinal Products Act (§§ 43 to 53) governs the sale of medicinal prodcucts, in particular the Pharmacy-only requirement, (§§ 43 to 46), rules regarding the medicinal products distribution channels (§§ 47 to 47 b), prescription requirements (§ 48), Retail trading of over-the-counter medicinal products (§ 50), Sale by itinerant traders (§ 51), self-service restrictions (§ 52), Wholesale trading of medicinal products (§ 52 a) and other details regarding brokering and consultation requirements.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
1. § 7 of the German Law Against Unfair Trade Practices regulates certain forms of advertising and promotion by means of electronic messages (based on the European E-Commerce Directive of 8 June 2000). It is illegal to unreasonably direct advertising to someone who does not wish to receive advertising. Marketing/advertising by telephone (‘cold calls’) directly to consumers is illegal, unless the consumer has given express consent. If the marketing/advertising is directed to any party other than a consumer who has not expressly consented, it is illegal unless there is express or implied consent. Advertising through automatic calling machines, telefax or electronic mail is illegal if the receiving party has not expressly consented to such advertising. Very narrow exceptions apply.
2. On publicly-available online advertising, an advertiser has to provide specific identifying information that is easily recognizable, directly accessible and consistently available. These criteria are met when it can be found under a clear headline such as ‘contact’ or ‘imprint’ on the homepage or not more than two clicks away from the homepage. The imprint must include (i) the full (company) name, postal address (not PO Box), and contact email address of advertiser, and, if the advertiser is a legal entity, the form of organization and the full name of the legal representative (CEO, Managing Director), (ii) the location of the commercial register in which the advertiser is registered, including its registration number, (iii) the VAT Identification number, if applicable. Additional requirements apply in certain circumstances.
3. Advertising in social networks (eg posts by influencers) needs to be marked as such, if the person posting the messages receives compensation for its participation in the ad. References such as ‘#ad’ or ‘#sponsored’ would not be sufficient, #werbung (English = advertisement) is normally ok. Social media advertisements must comply with all general advertising rules.
4. The liability of internet advertisers offering promotions is regulated by the Telemedia Act (Telemediengesetz of 26 February 2007, mosst recent amendment of 28 September 2017) implementing he EU Directive on E-Commerce. Service providers are not liable for the information transmitted if the provider has not initiated the transmission, selected the receiver of the transmission, or selected or modified the content contained in the transmission. There is service provider liability in all other cases.
The scope of liability is quite broad, including responsibility to take steps to avoid and prevent illegal acts. Service providers are not generally obliged to monitor their websites, but must act if made aware of a breach on their website.
20. May medicines and devices be advertised or sold directly to consumers?
Non-prescription medicines and devices may be advertised and sold directly consumers, subject to the restrictions of the German Health Advertising Law Heilmittelwerbegesetz) of 19 October 1994, amended most recently on 20 December 2016. For details of the laws governing advertising and sales of medicinal products and medical devices see the responses to question 38 above.
21. How is compliance monitored?
1. Compliance with sales and advertising restictions is monitored, and infringements prosecuted, by (i) competitors, (i) industry associations and (iii) to a limited extent by government authorities.
2. The main sector of governmental supervision relates to the manufacture and marketing of medicinal products. The competent authorities can inspect the manufacture, distribution and evaluation of medicinal product risks. In order to reduce risks, the authorities are involved in the co-ordination of necessary measures in enterprises and facilities that manufacture, place on the market or clinically test medicinal products. To this end, the representatives of the competent higher federal authority, in consultation with the competent authority, can enter the production areas and business premises during regular working hours, inspect documents including the pharmacovigilance master file and request information.
22. What are the potential penalties for noncompliance?
1. § 17 of the German Medicinal Products Act governs the criminal sanctions, penalties and fines in the case of a criminal violation of the medicinal products laws. Depending on the kind and circumstances of such criminal violation, the scope of sanctions ranges from imprisonment up to three years to monetary fines. As concerns criminal monetary fines, the court can impose a fine up to EUR 30.000 per day for the number of days determined by the court (max. 360 days) – „daily rate“, pursuant to § 40 of the German Criminal Code of 15 May 1871, as amended (most recent amendment of 30 October 2017). If a criminal violation (offense) is committed by a legal representative of a business, the company fine can be up to 10 million EUR (see paragraph 3 below).
2. Pursuant to the Act on Regulatory Offences of 24 May 1968, as amended (most recent amendment of 17 December 2018), an administrative fine for a regulatory violation can be a maximum of EUR 1,000.00, except where a higher amount is stated in a relevant law. The administrative fine shall in any case exceed the financial benefit which the perpetrator or the company has obtained from the offense (§ 17 para 4 Administrative Offenses Act).
3. Where an administrative or criminal offense, pursuant to one of the statutes regulating the manufacture and sale of a medicinal product, is committed by an individual acting as a legal representative of a company, the administrative fine can imposed on the company (§ 30 Administrative Offenses Act,
Such corporate money fine pusuant § 30 of the Regulatory Offences Act can be imposed in case of an offence commited by a management individual by which the company violates its obligations, or from which the company benefits or was intended to benefit. This applies to any regulatory offence, regardless of what the offence concerned (it can be any offence within the sector of medicinal products, medical devices, food safety or CLP Regulations). In case of an intentional offence, the maximum amount of a fine is € 10 million, plus the absorption/skimming off of profits derived from the violation. In case of a negligent offence, the maximum amount of a fine is € 5 million, plus said absorption of profits.
Limited or permanent revocation of regulatory and/or professional licenses is also possibility.