Judgment;Summary — ECLI:EU:C:2022:893
Date: 2022-11-17
Language of the case: Danish
Court formation: Fifth Chamber
Subject matter: Free movement of goods;Trade marks;Measures having equivalent effect;Intellectual, industrial and commercial property;Approximation of laws;Quantitative restrictions;Public health
Procedure: Reference for a preliminary ruling
Origin: Denmark

Translation C-224/20 — 1 
Case C-224/20 
Request for a preliminary ruling 
Date lodged: 
29 May 2020 
Referring court: 
Sø- og Handelsretten (Denmark) 
Date of the decision to refer: 
3 April 2020 
Applicants: 
Merck Sharp & Dohme B.V. 
Merck Sharp & Dohme Corp. 
MSD DANMARK ApS 
MSD Sharp & Dohme GmbH 
Novartis AG 
H. LUNDBECK A/S 
FERRING LÆGEMIDLER A/S 
Defendants: 
ABACUS MEDICINE A/S 
PARANOVA DANMARK A/S 
2CARE4 ApS 
  
SØ- OG HANDELSRETTEN (Maritime and Commercial Court) 
ORDER 
delivered on 3 April 2020 
EN 
REQUEST FOR A PRELIMINARY RULING OF 3. 4. 2020 — CASE C-224/20 
 
2  
Case [omissis] 
Merck Sharp & Dohme B.V.  
[omissis]  
and  
Merck Sharp & Dohme Corp.  
[omissis]  
and  
MSD DANMARK ApS  
[omissis] 
v 
ABACUS MEDICINE A/S  
[omissis] 
and 
Case [omissis] 
Novartis AG  
[omissis] 
v 
ABACUS MEDICINE A/S  
[omissis] 
and 
Case [omissis] 
Novartis AG  
[omissis] [OR. 2] 
v 
ABACUS MEDICINE A/S  
[omissis] 
and 
Case [omissis] 
Novartis AG  
[omissis] 
v 
MERCK SHARP & DOHME AND OTHERS 
 
3 
PARANOVA DANMARK A/S 
and 
Case [omissis] 
H. LUNDBECK A/S  
[omissis] 
v 
PARANOVA DANMARK A/S 
and 
Case [omissis] 
MSD DANMARK ApS  
[omissis]  
and  
MSD Sharp & Dohme GmbH  
[omissis]  
and 
Merck Sharp & Dohme Corp.  
[omissis] 
v 
2CARE4 ApS 
[OMISSIS] [OR. 3] 
and 
Case [omissis] 
FERRING LÆGEMIDLER A/S  
[omissis] 
v 
PARANOVA DANMARK A/S  
[omissis] 
The Sø- og Handelsretten [omissis] has decided to make a reference to the Court 
of Justice of the European Union for a preliminary ruling pursuant to Article 267 
of the Treaty on the Functioning of the European Union. 
REQUEST FOR A PRELIMINARY RULING OF 3. 4. 2020 — CASE C-224/20 
 
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The reference concerns in particular any consequences which the rules laid down 
in Directive 2011/62/EU of the European Parliament and of the Council of 8 June 
2011 amending Directive 2001/83/EC on the Community code relating to 
medicinal products for human use, as regards the prevention of the entry of 
falsified medicinal products into the legal supply chain, and Commission 
Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 
2001/83/EC of the European Parliament and of the Council by laying down 
detailed rules for the safety features appearing on the packaging of medicinal 
products for human use, may have for a parallel importer’s right to repackage 
medicinal products imported in parallel in new external packaging, as occurred in 
those cases. 
The dispute in the main proceedings and the relevant facts 
1. The seven present cases concern parallel imports/parallel distribution (hereinafter 
referred to jointly as ‘parallel imports’) and repackaging of medicinal products. 
The applicants are manufacturers of medicinal products and proprietors of the 
trade marks for the medicinal products which each of them manufactures and 
sells. The defendants carry out parallel imports into Denmark of medicinal 
products which the applicants have placed on the market in other countries of the 
European Union. 
2. The defendant parallel importers repackage the medicinal products imported in 
parallel in new external packaging to which they reaffix the applicants’ respective 
trade marks (product names) or in new external packaging to which they do not 
reaffix the applicants’ respective trade marks [OR. 4] (product names), but which 
they instead give a new product name before the medicinal products are marketed 
in Denmark. 
3. The question in these cases is whether the manufacturers of medicinal products 
are able to object to that repackaging, with the result that the parallel importers are 
required to market the medicinal products in Denmark in the same packaging as 
that in which they were marketed in the State of export and must therefore confine 
themselves to carrying out relabelling or supplementary labelling, replacing the 
package leaflet, attaching a new, unique identifier, and resealing the packaging by 
affixing a new device to verify whether the packaging has been tampered with 
(‘anti-tampering device’) on top of or in place of the broken anti-tampering 
device. 
4. The manufacturers of pharmaceutical products submit that the trade mark rules 
give a trade mark proprietor the right to object to repackaging in new external 
packaging in circumstances such as those in the main proceedings. The parallel 
importers argue that the repackaging in new external packaging is necessary and 
therefore lawful. 
5. The first case concerns the parallel import and repackaging of medicinal products 
manufactured and marketed by Merck Sharp & Dohme B.V. and others under the 
MERCK SHARP & DOHME AND OTHERS 
 
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EU trade marks Janumet, Januvia, Elonva, Stocrin, Bridion and Puregon. Abacus 
Medicine A/S purchases Janumet, Januvia, Elonva, Stocrin, Bridion and Puregon 
in other countries of the European Union and places them on the market in 
Denmark after repackaging them in new external packaging, to which the trade 
mark has been reaffixed. 
6. The next three cases concern the parallel import and repackaging of medicinal 
products manufactured and marketed by Novartis AG under the EU trade marks 
Travatan, Eucreas and Miflonide. The defendant in two of the cases, Abacus 
Medicine A/S, purchases Travatan and Eucreas in other countries of the European 
Union and places them on the market in Denmark after repackaging them in new 
external packaging, to which the trade mark has been reaffixed. The defendant in 
the latter case, Paranova Danmark A/S, purchases Miflonide in other countries of 
the European Union and places them on the market in Denmark after repackaging 
them in new external packaging, to which the trade mark has been reaffixed. 
7. The fifth case concerns the parallel import and repackaging of medicinal products 
manufactured and marketed by H. Lundbeck A/S under the EU trade marks 
Brintellix and Clopixol. Paranova Danmark A/S purchases Brintellix and Clopixol 
in other countries of the European Union and places them on the market in 
[OR. 5] Denmark after repackaging them in new external packaging, to which the 
respective product-specific trade mark has been reaffixed, but without reaffixing 
the other trade marks and commercial indications which H. Lundbeck A/S had 
affixed to the original external packaging. 
8. The sixth case concerns the parallel import and repackaging of a medicinal 
product manufactured and marketed by a company in the Merck Sharp & Dohme 
group in Germany under the trade mark Nacom. In Denmark Merck Sharp & 
Dohme B.V. and others market the medicinal product under the trade mark 
Sinemet. 2Care4 ApS purchases Nacom in Germany and places it on the market in 
Denmark, after repackaging it in new external packaging which bears the product 
name ‘Carbidopa/Levodopa 2care4’, and at the same time states, as required by 
the Danish Medicines Agency, that the packaging contains a blister packet marked 
Nacom. 2Care4 ApS reuses the original blister packet bearing the German trade 
mark Nacom, which belongs to MSD Sharp & Dohme GmBH, and the EU trade 
mark MSD, which belongs to Merck Sharp & Dohme Corp. As required by the 
Danish Medicines Agency, 2Care4 ApS has printed its product name, 
‘Carbidopa/Levodopa 2care4’, on one side of the blister packet. The new package 
leaflet states that the product corresponds to Sinemet. 
9. The seventh case concerns the parallel import and packaging of two strengths of a 
medicinal product manufactured by Ferring B.V. In Denmark the medicinal 
product is marketed by Ferring Lægemidler A/S under the EU trade mark 
Nocdurna. However, the UK Medicines and Health Care Products Regulatory 
Agency objected to the use of the name Nocdurna and therefore the medicinal 
product is marketed in the UK under the trade mark Noqdirna. Paranova Danmark 
A/S purchases the medicinal product in the UK and places it on the market in 
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Denmark after repackaging it in new external packaging which bears the product 
name ‘Desmopressin Paranova’. The new external packaging also states that the 
medicinal product is manufactured by Ferring GmbH, that the medicinal product 
corresponds to the medicinal product Nocdurna, that Nocdurna is a registered 
trade mark belonging to Ferring B.V and that the packaging contains blister 
packets marked Noqdirna. Paranova Danmark A/S reuses the original blister 
packets but has printed, as required by the Danish Medicines Agency, the product 
name ‘Desmopressin Paranova’ on one side of the blister packets. The other side 
of the blister packets is unchanged and states that the medicinal product is called 
‘Noqdirna’ and originates from ‘Ferring’. The new external packaging contains a 
new package leaflet which states that the medicinal product corresponds to the 
medicinal product Nocdurna. [OR. 6] 
10. The first five cases have the following in common: 
- in most of the cases, the parallel importers market, in Denmark, medicinal 
products imported in parallel in the same packaging sizes as those used by 
each of the manufacturers of the medicinal products for the initial marketing 
of the medicinal products concerned in the European Union, 
- in several of those cases, the Danish Medicines Agency referred to its 
guidelines (Q&A) when asked specifically about the possibility of additional 
labelling, 
- prior to marketing in Denmark, the parallel importers broke the original anti-
tampering devices and opened the packaging in order to replace the package 
leaflets and/or attach new labels to the inner packaging, and 
- prior to marketing in Denmark, the parallel importers repackaged the 
medicinal products imported in parallel in new external packaging and 
reaffixed the applicants’ respective trade marks (product names) thereto. 
The final two cases have the following in common: 
- the parallel importers market the medicinal products in Denmark imported in 
parallel in the same packaging sizes as those used by each of the 
manufacturers of the medicinal products for the initial marketing of the 
medicinal products concerned in the European Union, 
- prior to marketing in Denmark, the parallel importers broke the original anti-
tampering devices and opened the packaging in order to replace the package 
leaflets and/or attach new labels to the inner packaging, and 
- prior to marketing in Denmark, the parallel importers repackaged the 
medicinal products imported in parallel in new external packaging to which 
the applicants’ respective trade marks (product names) were not reaffixed, 
but which were instead given new product names. Furthermore, the package 
leaflet states that the medicinal products correspond to the medicinal 
MERCK SHARP & DOHME AND OTHERS 
 
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products marketed by each of the applicants under their respective trade 
marks (product names). [OR. 7] 
Provisions of [EU] law and [EU] case-law 
Trade marks 
11. Article 15 of Directive (EU) 2015/2436 of the European Parliament and of the 
Council of 16 December 2015 to approximate the laws of the Member States 
relating to trade marks (‘the Trade Mark Directive’) concerns exhaustion of the 
rights conferred by a trade mark. Under Article 15, a trade mark is not to ‘entitle 
the proprietor to prohibit its use in relation to goods which have been put on the 
market in the Union under that trade mark by the proprietor or with the 
proprietor’s consent’ (paragraph 1) unless ‘there exist legitimate reasons for the 
proprietor to oppose further commercialisation of the goods, especially where the 
condition of the goods is changed or impaired after they have been put on the 
market.’ (paragraph 2). 
12. EU trade marks registered with the same legal effects throughout the European 
Union are governed by Regulation (EU) 2017/1001/EU of the European 
Parliament and of the Council of 14 June 2017 on the European Union trade mark 
(‘the Trade Mark Regulation’), Article 15 of which contains a provision which is 
essentially identical to Article 15 of the Trade Mark Directive. 
13. In connection with Articles 34 and 36 [TFEU] (formerly Articles 28 and 30 TEC) 
[omissis] the Court of Justice has ruled on the interpretation of Article 15(2) of the 
Trade Mark Directive (corresponding to Article 7(2) in the previous version 
thereof) in a range of judgments concerning the repackaging of medicinal 
products imported in parallel, in particular in the judgments in Joined Cases 
C-427/93, C-429/93 and C-436/93, Bristol-Myers Squibb and Others 
(ECLI:EU:C:1996:282); Case C-443/99, Merck, Sharp & Dohme 
(ECLI:EU:C:2002:245); Case C-143/00 Boehringer Ingelheim and Others 
(ECLI:EU:C:2002:246) (‘Boehringer I’); Case C-348/04, Boehringer Ingelheim 
and Others (ECLI:EU:C:2007:249) (‘Boehringer II’); and Case C-297/15, Ferring 
(ECLI:EU:C:2016:857). 
In those judgments the Court of Justice of the European Union found, inter alia, as 
follows: 
- the specific purpose of a mark is to guarantee the origin of the product 
bearing that mark and that a repackaging of that product carried out by a 
third party without the authorisation of the proprietor is likely to create real 
risks for that guarantee of origin (see paragraph 14 of Boehringer II and 
paragraph 14 of Ferring); 
- the change brought about by any repackaging of a trade-marked 
pharmaceutical product — creating by its very nature the risk [OR. 8] of 
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interference with the original condition of the product — may therefore be 
prohibited by the trade mark proprietor unless it is established that reliance 
on trade mark rights by the proprietor in order to oppose the marketing of 
repackaged products under that trade mark would contribute to the artificial 
partitioning of the markets between Member States. A trade mark 
proprietor’s opposition to repackaging contributes to artificial partitioning of 
the markets where the repackaging is necessary in order to enable the 
marketing of the products imported in parallel in the importing State and the 
legitimate interests of the proprietor are also safeguarded (see paragraph 56 
of Bristol-Myers Squibb and Others, paragraphs 18 and 19 of Boehringer II, 
and paragraphs 18 and 19 of Ferring); 
- repackaging must be regarded as having been carried out in circumstances 
not capable of affecting the original condition of the product where, for 
example, the trade mark proprietor has placed the product on the market in 
double packaging and the repackaging affects only the external layer, 
leaving the inner packaging intact, or where the repackaging is carried out 
under the supervision of a public authority in order to ensure that the product 
remains intact (see paragraph 60 of Bristol-Myers Squibb and Others); 
- while the trade mark proprietor may oppose the parallel importer’s use of 
replacement packaging, that is conditional on the relabelled pharmaceutical 
product being able to have effective access to the market concerned (see 
paragraph 29 of Merck, Sharp & Dohme and paragraph 50 of Boehringer I); 
- the criterion that the repackaging is to be necessary must be assessed in the 
light of the circumstances prevailing at the time of marketing in the 
importing State, which render repackaging objectively necessary for the 
medicinal product to obtain effective access to the market in the importing 
State (see paragraph 25 of Merck, Sharp & Dohme and paragraph 20 of 
Ferring); 
- the condition that packaging be necessary is directed only at the fact of 
repackaging the product — and the choice between a new carton and 
oversticking — for the purposes of allowing the product to be marketed in 
the importing Member State and not at the manner or style in which it has 
been repackaged (see paragraphs 38 and 39 of Boehringer II); 
- the trade mark proprietor cannot oppose the repackaging of the medicinal 
product in new external packaging when the size of packet used by the 
proprietor in the exporting State cannot be marketed in the importing State 
by reason, in particular, of rules on [OR. 9] packaging size, a national 
practice of using packaging only of a certain size, sickness insurance rules or 
well-established medical prescription practices based on standard sizes 
recommended by professional groups and sickness insurance institutions 
(see paragraph 53 of Bristol-Myers Squibb and Others and paragraph 21 of 
Ferring). 
MERCK SHARP & DOHME AND OTHERS 
 
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- conversely, a trade mark proprietor may object to the continued marketing of 
a medicinal product which a parallel importer has repackaged in a new, 
outer packaging and to which it has reaffixed the trade mark, where the 
medicinal product can be marketed in the importing State in the packaging 
which was used for marketing the medicinal product in the exporting State 
(see paragraph 29 of Ferring) as in that situation the trade mark proprietor 
can require the parallel importer to reuse the original packaging and merely 
affix to the original external or inner packaging new labels in the language 
of the importing State and add a new package leaflet in the language of the 
importing State (see paragraph 55 of Bristol-Myers Squibb and Others, 
paragraph 28 of Merck, Sharp & Dohme; and paragraph 49 of Boehringer I). 
- the condition that repackaging be necessary to market the medicinal product 
in the importing State is not fulfilled if the repackaging of the medicinal 
product is explicable solely by the parallel importer’s attempt to secure a 
commercial advantage (see paragraph 27 of Merck, Sharp & Dohme and 
paragraph 37 of Boehringer II); 
- resistance to relabelled pharmaceutical products does not always mean that 
repackaging, in the form of a replacement packaging, is necessary (see 
paragraph 51 of Boehringer I), but there may exist on a market, or on a 
substantial part of it, such strong resistance from a significant proportion of 
consumers to relabelled pharmaceutical products that there must be held to 
be a hindrance to effective market access. In those circumstances, a 
repackaging of the pharmaceutical products would not be explicable solely 
by the attempt to secure a commercial advantage, but also has the purpose of 
achieving effective market access (see paragraph 52 of Boehringer I); 
- the presentation of the repackaged product must not be such as to be liable to 
damage the reputation of the trade mark and of its proprietor (see 
paragraph 76 of Bristol-Myers Squibb and Others and paragraph 40 of 
Boehringer Ingelheim II); and 
- the fact that a parallel importer does not affix the trade mark to the new 
exterior packaging (‘de-branding’) or applies either its own logo or a house-
style (‘co-branding’) is, in principle, liable to damage the trade mark’s 
reputation [OR. 10] (see paragraph 45 of Boehringer II). The question 
whether those circumstances damage the trade mark’s reputation is a 
question of fact for the national court to decide in the light of the 
circumstances of each case (see paragraph 46 of Boehringer II). 
- it is for the parallel importer to prove the existence of the conditions 
preventing the trade mark proprietor from lawfully opposing further 
marketing of those medicinal products (see paragraph 23 of Ferring). As 
regards the condition that it must be shown that the repackaging cannot 
affect the original condition of the product inside the packaging, and a 
fortiori the condition that the presentation of the repackaged product must 
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not be such as to be liable to damage the reputation of the trade mark and of 
its proprietor, it is sufficient, however, that the parallel importer furnishes 
evidence that leads to the reasonable presumption that that condition has 
been fulfilled (see paragraphs 52 and 53 of Boehringer II). 
The obligation to affix and verify safety features on the packaging of medicinal 
products 
14. On 9 February 2019 [omissis] Directive 2011/62/EU [omissis] (‘Directive 
2011/62’) and [omissis] Regulation (EU) 2016/161 [omissis] (‘Regulation 
2016/161’) entered into force. 
15. The provisions of Directive 2011/62 and Regulation 2016/161 seek to prevent 
medicinal products which are falsified in relation to their identity, history or 
source from entering the legal supply chain of medicinal products, which poses a 
particular threat to human health and may lead to a lack of trust of the patient also 
in the legal supply chain (see recitals 2 and 3 of Directive 2011/62). 
16. Article 1(11) and (12) of Directive 2011/62 inserted, inter alia, a new point (o) of 
Article 54 and a new Article 54a of Directive 2001/83/EC on the Community code 
relating to medicinal products [OR. 11] for human use (‘the Medicinal Products 
Directive’) [omissis]. Article 54a, in conjunction with point (o) of Article 54, 
provides that the packaging of the medicinal products is to bear two safety 
features, namely a unique identifier allowing verification the authenticity of the 
medicinal product (unique identifier/UI), and an anti-tampering device allowing 
verification of whether the outer packaging has been tampered with (anti-
tampering device/ATD). 
17. Article 10 of Regulation 2016/161 provides that when verifying the safety 
features, ‘manufacturers, wholesalers and persons authorised or entitled to supply 
medicinal products to the public’ are to verify the authenticity of the unique 
identifier and the integrity of the anti-tampering device. Articles 24 and 30 of 
Regulation 2016/161 further provide that ‘wholesalers’ and ‘persons authorised 
or entitled to supply medicinal products to the public’ may not resell or supply 
medicinal products where they have reason to believe that the packaging of the 
medicinal product has been tampered with or in case of suspected falsification. 
18. With reference to the case-law of the Court of Justice of the European Union, 
recitals 21 to 24 of Directive 2011/62 state that account should be taken of the fact 
that specific conditions for retail supply of medicinal products to the public have 
not been harmonised at Union level and, therefore, Member States may impose 
conditions for supplying medicinal products to the public within the limits of the 
EU Treaty. 
19. Finally, recital 29 of Directive 2011/62 states: 
MERCK SHARP & DOHME AND OTHERS 
 
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‘This directive is without prejudice to provisions concerning intellectual property 
rights. It aims specifically to prevent falsified medicinal products from entering 
the legal supply chain.’ 
Parallel imports and replacement of safety features on the packaging of medicinal 
products 
20. Recital 12 of Directive 2011/62 is worded as follows: 
‘Any actor in the supply chain who packages medicinal products has to be a 
holder of a manufacturing authorisation. In order for the safety features to be 
effective, a manufacturing authorisation holder who is not himself the original 
manufacturer of the medicinal product should only be permitted to remove, 
replace or cover those safety features under [OR. 12] strict conditions. In 
particular, the safety features should be replaced in the case of repackaging by 
equivalent safety features. To this end, the meaning of the term “equivalent” 
should be clearly specified. Those strict conditions should provide adequate 
safeguards against falsified medicinal products entering the supply chain, in 
order to protect patients as well as the interests of marketing authorisation 
holders and manufacturers.’ 
21. Article 47a of the Medicinal Products Directive, which was inserted by 
Article 1(8) of Directive 2011/62, provides that the holder of a manufacturing 
authorisation, including a parallel importer, may not remove or cover, either fully 
or partially, the safety features referred to in point (o) of Article 54 (a unique 
identifier and anti-tampering device), unless a number of specific conditions are 
satisfied. 
22. Article 16 of Regulation 2016/161 contains a provision which, with reference to 
Article 47a of the Medicinal Products Directive, sets out the verifications to be 
performed before removing or covering the safety features. 
23. The European Commission drew up and published a document entitled ‘Questions 
and Answers’, which is regularly updated, in response to a series of questions 
concerning the rules relating to safety features on the packaging of medicinal 
products. The answers to Questions 1.20 to 1.22 (as set out in version 17, 
published on 9 March 2020) describe the precautions which a parallel importer is 
to take when replacing the original security features. 
24. The European Commission set up an expert group, ‘Delegated act on safety 
features for medicinal products for human use’ (E02719) (‘Commission expert 
group on safety features’). The published minutes of the expert group’s meetings 
show that it discussed the interpretation of Article 47a of Directive 2011/62. 
25. The European Medicines Agency (‘EMA’) dealt with parallel imports and safety 
features in its ‘Frequently asked questions about parallel distribution’ (‘EMA’s 
Q&A’). Point 7 of the ‘Parallel distribution notification check’ section states, 
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under point 2 of the heading ‘Exceptions’, that a person who breaks ‘the seal’ to 
attach new labels to the packaging or replace the package leaflet and then seals the 
original packaging with ‘a clear seal’, is to remove [OR. 13] the indication 
‘Sealed pack. Do not use if box has been opened’ and replace it with ‘Sealed pack 
has been opened for the purpose of parallel distribution’. The relevant section of 
the EMA’s Q&A was inserted before Directive 2011/62 was adopted. None of the 
relevant EMA-approved products covered by the cases contains the indication 
‘sealed pack’ in the relevant annexes. 
Provisions of national law and national case-law 
26. The Trade Mark Directive was transposed into Danish law by the 
Varemærkeloven (Law on trade marks), Paragraph 10a of which contains a 
provision which is essentially identical to Article 15 of the Trade Mark Directive. 
27. Like the manufacturers of medicinal products, parallel importers of medicinal 
products operate on the basis of rules on authorisation and public oversight. Thus, 
medicinal products imported in parallel may be marketed in Denmark only if the 
parallel importer is the holder of a marketing authorisation to import in parallel 
under Chapter 4 of Bekendtgørelse nr. 1239 af 12. december 2005 om 
markedsføringstilladelse til lægemidler m.m (Order No 1239 of 12 December 
2005 on marketing authorisations for medicinal products etc.). A medicinal 
product imported in parallel is at all times subject to the conditions which apply to 
directly imported medicinal products (see Paragraph 38 of the order). Parallel 
importers which carry out additional labelling or repackaging in new external 
packaging in order to meet the conditions for marketing in Denmark must hold, in 
addition to a marketing authorisation, a manufacturing authorisation under 
Chapter 3 of the Lægemiddelloven (Law on medicinal products). 
28. Article 54a of the Medicinal Products Directive, relating to safety features on the 
packaging of medicinal products, was transposed into Danish law, with effect 
from 9 February 2019, by the insertion of Paragraph 59a into the Law on 
medicinal products (see Lovbekendtgørelse nr. 99 af 16. januar 2018 
(Consolidated Law No 99 of 16 January 2018; ‘the Law on medicinal products’). 
The relevant parts of Paragraph 59a are worded as follows: 
‘Medicinal products at risk of falsification shall have safety features attached to 
their packaging in accordance with the regulation on safety features (see 
subparagraphs 2 and 3). The safety features shall consist of a unique identifier 
allowing verification of the authenticity of the medicinal product and 
identification of the individual packaging, and an anti-tampering device allowing 
verification of whether the packaging of the medicinal product has been tampered 
with. 
Subparagraph 2. Manufacturers of prescription medicinal products for human use 
shall provide medicinal products with safety features. … [OR. 14] 
MERCK SHARP & DOHME AND OTHERS 
 
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Subparagraph 5. The Ministry of Health and Senior Citizens may lay down 
specific rules to underpin the purpose and function of safety features.’ 
29. On 18 December 2018, the Danish Medicines Agency published a series of 
‘Questions and Answers about safety features on the packaging of medicinal 
products’ (‘Danish Medicines Agency’s Q&A’), which were most recently 
updated on 20 January 2020 and which state, inter alia, as follows under the 
heading ‘Parallel imports’: 
‘28. Would it be against the regulation for a parallel importer to replace the 
anti-tampering device with another device? 
Yes. The Danish Medicines Agency considers that it is a general rule that parallel 
importers must repackage the products in new packaging according to the new 
rules of the regulation. That also follows from the purpose of the new rules of the 
regulation, including the requirement for an anti-tampering device to be designed 
in such a way that any opening of, or tampering with, the package can be 
identified. Parallel importers which open the packaging of medicinal products 
and break the anti-tampering device for the purpose of placing a Danish package 
leaflet etc. in the packaging must therefore, in accordance with the new rules of 
the regulation, repackage the products in new packaging and attach a new unique 
identifier and anti-tampering device on the packaging, as well as upload 
information etc. 
The Commission stated in its Q&A that, under certain specific conditions, it is 
possible for parallel importers “lawfully” to open the packaging of medicinal 
products with a view, inter alia, to placing a new package leaflet in the packaging 
and then replace the original anti-tampering device with a new anti-tampering 
device, provided it is carried out under the supervision of the competent 
authorities and provided the new anti-tampering device seals the packaging 
completely and covers all visible signs of the lawful opening. In addition, the 
replacement of the anti-tampering device must be carried out in accordance with 
the GMP (Good Manufacturing Practice) for medicinal products and a parallel 
importer who lawfully opens the packaging of medicinal products and attaches a 
new anti-tampering device must verify beforehand the authenticity of the unique 
identifier and the integrity of the anti-tampering device on the original packaging 
in accordance with Article 47a(1)(a) of Directive 2001/83/EC. 
Since it is, as mentioned above, a general rule that parallel importers must, under 
the new rules of the regulation, repackage the products in new packaging, the 
Danish Medicines Agency considers that the exemption described [OR. 15] by the 
Commission can be applied only in exceptional situations, including, for example, 
where there is a risk to the supply of medicinal products. 
In Denmark, the exemption cannot in principle be used in connection with a new 
application for marketing authorisation for parallel imports. Those applications 
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will have to satisfy the general requirements, including the general rule that 
medicinal products must be repackaged in new packaging. 
The exemption, as described by the Commission, will mean that, where a 
marketing authorisation for parallel import for the specific product has been 
issued, where the medicinal product is marketed and where a parallel importer, in 
a specific and limited situation, wishes to make use of the exemption from the 
general rule on repackaging, parallel importers may apply for an exemption by 
submitting an application for an exemption from the order on marketing … In 
addition to following that guidance, parallel importers must adequately describe 
how they intend to replace the anti-tampering device, submitting pictures of both 
the original anti-tampering device and the new anti-tampering device. In addition, 
it must be demonstrated that the replacement of the anti-tampering device will be 
carried out in accordance with the GMP rules and in such a way that the new 
anti-tampering device completely seals the packaging and covers all visible signs 
of the lawful opening. Furthermore, an exemption should cover all the products 
concerned, including the form and strength and the related countries of export.’ 
30. Finally, in Denmark there is a rule on generic substitution (see Paragraph 62(1) of 
Bekendtgørelse nr. 1297 af 28. november 2019 om recepter og dosisdispensering 
af lægemidler (Order No 1297 of 28 November 2019 on prescriptions and unit 
dispensing of medicinal products)), which, as a rule, requires pharmacists to 
supply the cheapest medicinal product within a category of approved medicinal 
products which may replace the medicinal product indicated by the doctor 
(substitution). 
The questions referred 
31. Since clarification of the questions is of decisive importance to the outcome of the 
present cases and the doubts raised concern the interpretation of the rules of EU 
law, the Sø- og Handelsretten considers that it is necessary to ask the Court of 
Justice of the European Union to answer the questions below. 
It is hereby ordered: 
The Sø- og Handelsretten requests the Court of Justice to answer the following 
questions: [OR. 16] 
Question 1: 
Must Article 15(2) of Directive 2015/2436/EU of the European Parliament and of 
the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU of the 
European Parliament and of the Council on the EU trade mark be interpreted as 
meaning that a trade mark proprietor may oppose further commercialisation of a 
medicinal product which a parallel importer has repackaged in new external 
packaging to which the trade mark has been reaffixed, where 
MERCK SHARP & DOHME AND OTHERS 
 
15 
(i) the importer is able to achieve packaging which may be marketed and gain 
effective access to the market of the Member State of importation by 
breaking the original external packaging in order to affix new labels to the 
inner packaging and/or replace the package leaflet and then reseal the 
original external packaging with a new device to verify whether the 
packaging has been tampered with, in accordance with Article 47a of 
Directive 2001/83/EC of the European Parliament and of the Council of 
6 November 2001 on medicinal products (as amended by Directive 
2011/62/EU of the European Parliament and of the Council) and Article 16 
of Commission Delegated Regulation (EU) 2016/161 on safety features 
appearing on the packaging of medicinal products? 
(ii) the importer is not able to achieve packaging which may be marketed and 
gain effective access to the market of the Member State of importation by 
breaking the original external packaging in order to affix new labels to the 
inner packaging and/or replace the package leaflet and then reseal the 
original external packaging with a new device to verify whether the 
packaging has been tampered with, in accordance with Article 47a of 
Directive 2001/83/EC of the European Parliament and of the Council of 
6 November 2001 on medicinal products (as amended by Directive 
2011/62/EU of the European Parliament and of the Council) and Article 16 
of Commission Delegated Regulation (EU) 2016/161 on safety features 
appearing on the packaging of medicinal products? 
Question 2: 
Must Directive 2001/83/EC of the European Parliament and of the Council on 
medicinal products (as amended by Directive 2011/62/EU), including, in 
particular, Articles 47a and point (o) of Article 54, be interpreted as meaning that 
a new device to verify whether the packaging has been tampered with (anti-
tampering device), affixed to the original packaging of the medicinal products (in 
connection with additional labelling after the packaging has been opened in such a 
way that the original anti-tampering device has been fully or partially covered 
and/or removed), within the meaning of Article 47a(1)(b), ‘[is] equivalent as 
regards the possibility to verify the authenticity, identification and to provide 
evidence of tampering [with] the medicinal product’ and, within [OR. 17] the 
meaning of Article 47a(1)(b)(ii), ‘‘[is] equally effective in enabling the 
verification of authenticity and identification of medicinal products and in 
providing evidence of tampering with medicinal products’, where the packaging 
of the medicinal products (a) displays visible signs that the original anti-tampering 
device has been tampered with, or (b) that can be established by touching the 
product, including 
(i) through mandatory verification of the integrity of the anti-tampering device 
carried out by the manufacturers, wholesalers, pharmacists and persons 
authorised or entitled to supply medicinal products to the public (see 
Directive 2011/62/EU of the European Parliament and of the Council, 
REQUEST FOR A PRELIMINARY RULING OF 3. 4. 2020 — CASE C-224/20 
 
16  
Article 54a(2)(d) and Commission Delegated Regulation 2016/161, 
Article 10(b) and Articles 25 and 30), or 
(ii) after the packaging of the medicinal products has been opened, for example 
by a patient? 
Question 3: 
If the answer to Question 2 is in the negative: 
Must Article 15 of Directive 2015/2436/EU of the European Parliament and of the 
Council on trade marks, Article 15 of Regulation 2017/1001/EU of the European 
Parliament and Council on EU trade marks, and Articles 36 and 34 TFEU, then be 
interpreted as meaning that repackaging in new external packaging is objectively 
necessary for effective access to the market of the State of importation, where it is 
not possible for the parallel importer to affix additional labelling and reseal the 
original packaging in accordance with Article 47a of Directive 2001/83/EC of the 
European Parliament and of the Council of 6 November 2001 on medicinal 
products (as amended by Directive 2011/62/EU of the European Parliament and of 
the Council), that is to say without the packaging of the medicinal products (a) 
displaying visible signs that the original anti-tampering device has been tampered 
with, or (b) that can be established by touching the product, as described in 
Question 2, in a manner which is not in accordance with Article 47a? 
Question 4: 
Must Directive 2001/83/EC of the European Parliament and of the Council on 
medicinal products (as amended by Directive 2011/62/EU of the European 
Parliament and of the Council) and Commission Delegated Regulation (EU) 
2016/161, in conjunction with Articles 34 and 36 TFEU and Article 15(2) of 
Directive 2015/2436/EU of the European Parliament and of the Council on trade 
marks, be interpreted as meaning that a Member State (in Denmark: the 
Lægemiddelstyrelsen (Danish Medicines Agency)) is entitled to lay down 
guidelines, in accordance with which, in general, repackaging in new external 
packaging is to be carried out and it is only on application, in exceptional cases 
(for example where there is a risk to the supply of the medicinal product), that 
[OR. 18] additional labelling and resealing may be permitted to be carried out by 
attaching new security features to the original external packaging, or is the 
Member State’s issuing and observance of such guidelines incompatible with 
Articles 34 and 36 TFEU and/or Article 47a of Directive 2001/83/EC of the 
European Parliament and of the Council on medicinal products and Article 16 of 
Commission Delegated Regulation (EU) 2016/161? 
Question 5: 
Must Article 15(2) of Directive 2015/2436/EU of the European Parliament and of 
the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU of the 
European Parliament and of the Council on trade marks, in conjunction with 
MERCK SHARP & DOHME AND OTHERS 
 
17 
Articles 34 and 36 TFEU, be interpreted as meaning that repackaging in new 
external packaging carried out by a parallel importer in accordance with the 
guidelines laid down by a Member State, as referred to in Question 4, must be 
regarded as necessary for the purposes of the case-law of the Court of Justice of 
the European Union, 
(i) where such guidelines are compatible with Articles 34 and 36 TFEU and the 
case-law of the Court of Justice of the European Union on parallel imports 
of medicinal products? 
(ii) where such guidelines are incompatible with Articles 34 and 36 TFEU and 
the case-law of the Court of Justice of the European Union on parallel 
imports of medicinal products? 
Question 6: 
Must Articles 34 and 36 TFEU be interpreted as meaning that the repackaging of a 
medicinal product in new external packaging must be objectively necessary for 
effective access to the market of the importing State, even if the parallel importer 
has not reaffixed the original trade mark (product name), but instead given the 
new external packaging a product name which does not contain the trade mark 
proprietor’s product trade mark (‘de-branding’)? 
Question 7: 
Must Article 15(2) of Directive 2015/2436/EU of the European Parliament and of 
the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU of the 
European Parliament and of the Council on EU trade marks be interpreted as 
meaning that a trade mark proprietor may oppose further commercialisation of a 
medicinal product which a parallel importer has repackaged in a new external 
packaging, in so far as the parallel importer has reaffixed only the trade mark 
proprietor’s product-specific trade mark, but has not reaffixed the other trade 
marks [OR. 19] and/or commercial indications which the trade mark proprietor 
had affixed to the original external packaging? 
[omissis]