EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 26.4.2023  
COM(2023) 193 final  
ANNEXES 1 to 5  
 
ANNEXES  
to the proposal for a  
Regulation of the European Parliament and of the Council  
laying down Union procedures for the authorisation and supervision of medicinal 
products for human use and establishing rules governing the European Medicines 
Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and 
repealing Regul ation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation 
(EC) No 1901/2006  
{SEC(2023)  390 final}  - {SWD(2023)  192 final}  - {SWD(2023)  193 final}  -
 {SWD(2023)  194 final}    
EN 1  EN ANNEX I  
MEDICINAL PRODUCTS TO BE AUTHORISED BY THE UNION  
1. Medicinal products developed by means of one of the following biotechnological 
processes:  
– recombinant nucleic acid technology;  
– controlled expression of genes coding for biologically active proteins in 
prokaryotes and eukaryotes including transformed mammalian cells.  
2. Advanced therapy medicinal products as defined in Article  2 of Regulation (EC) 
No 1394/2007.  
3. Medicinal products for human use containing an active substance which on 20 May 
2004 was not authorised in the Union, excluding allergen products or herbal 
medicinal products, which shall in any case not be authorised by the Union.   
4. Medicinal products that are designated as orphan medicinal products pursuant to this 
Regulation.  
5. Medicinal products authorised in accordance with a paediatric use marketing 
authorisation.  
6. Priority antimicrobials as referred to in Arti cle 40.   
EN 2  EN ANNEX II  
LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 172  
(1) the obligation to submit complete and accurate particulars and documentation in an 
application for marketing authorisation submitted to the Agency or in response to 
obligations laid down in this Regulation to the extent that the failure to comply with 
the obligation concerns a material particular;  
(2) the obligation to comply with conditions or restrictions included in the mar keting 
authorisation and concerning the supply or use of the medicinal product for human 
use, as referred to in Article 12 (4), point (c) and in Article 13(1) fourth 
subparagraph;  
(3) the obligation to comply with conditions or restrictions included in the  marketing 
authorisation with regard to the safe and effective use of the medicinal product for 
human use as referred to in Article 12(4), points (b), (d), (e), (f) and (g) and in 
Article 13(1);  
(4) the obligation to introduce any necessary variation to th e terms of the marketing 
authorisation to take account of technical and scientific progress and enable the 
medicinal products for human use to be manufactured and checked by means of 
generally accepted scientific methods, as provided for in Article 45(1);  
(5) the obligation to supply any new information which may entail a variation to the 
terms of the marketing authorisation, to notify any prohibition or restriction imposed 
by the competent authorities of any country in which the medicinal product for 
human  use is marketed, or to supply any information that may influence the 
evaluation of the risks and benefits of the product, as provided for in Article 45(2);  
(6) the obligation to keep product information up to date with current scientific 
knowledge, includ ing the conclusions of the assessment and recommendations made 
public on the European medicines web -portal, as provided for in Article 45(3);  
(7) the obligation to provide, at the request of the Agency, any data demonstrating that 
the benefit -risk balance remains favourable, as provided for in Article 45(4);  
(8) the obligation to place the medicinal product for human use on the market in 
accordance with the content of the summary of product characteristics and the 
labelling and package leaflet as contained in the marketing authorisation;  
(9) the obligation to comply with the conditions referred to in Article 18(1) and Article 
19; 
(10) the obligation to notify the Agency of the dates of actual marketing and of the date 
when the medicinal product for human use  ceases to be on the market, and to provide 
to the Agency data relating to the volume of sales and the volume of prescriptions of 
the medicinal product for human use, as provided in Article 16(4);  
(11) the obligation to operate a comprehensive pharmacovigi lance system for the 
fulfilment of pharmacovigilance tasks, including the operation of a quality system, 
maintenance of a pharmacovigilance system master file and performance of regular 
audits, in accordance with Article 99 in conjunction with Article 99 o f [revised 
Directive 2001/83/EC];  
(12) the obligation to submit, at the request of the Agency, a copy of the 
pharmacovigilance system master file, as provided for in Article 45(4);   
EN 3  EN (13) the obligation to operate a risk management system as provided for in Article 22 and 
Article 99(2) in conjunction with Article 99(4) of [revised Directive 2001/83/EC];  
(14) the obligation to record and report suspected adverse reactions for medicinal 
products for human use, in accordance with Article 106 (1) in conjunction w ith 
Article 105 of [revised Directive 2001/83/EC];  
(15) the obligation to submit periodic safety update reports, in accordance with Article 
106(2) in conjunction with of [revised Directive 2001/83/EC];  
(16) the obligation to conduct post -marketing studies,  including post -authorisation safety 
studies and post -authorisation efficacy studies, and to submit them for review, as 
provided for in Article 20;  
(17) the obligation to ensure that public announcements relating to information on 
pharmacovigilance concern s are presented objectively and are not misleading and to 
notify them to the Agency, as provided for in Articles 104 of [revised Directive 
2001/83/EC];  
(18) the obligation to comply with the time limits for initiating or completing measures 
specified in the Agency’s decision on deferral following the initial marketing 
authorisation of the medicinal product for human use concerned and in accordance 
with the definitive opinion referred to in Article 81(2);  
(19) the obligation to submit to the Agency an upda ted version of the paediatric 
investigation plan in accordance with the agreed timing as provided for in Article 
74(2) and Article 74(3);  
(20) the obligation to place the medicinal product for human use on the market within two 
years of the date on which t he paediatric indication is authorised, as provided for in 
Article 59 of [revised Directive 2001/83/EC];  
(21) the obligation to notify the Agency the intention to discontinue the placing on the 
market of the product no less than six months before the disco ntinuation as provided 
for in Article 60 of [revised Directive 2001/83/EC];  
(22) the obligation to transfer the marketing authorisation or to allow a third party to use 
documentation contained in the file of the medicinal product, as provided for in 
Articl e 60 of [revised Directive 2001/83/EC];  
(23) the obligation to notify the Agency of the intention to discontinue the conduct of an 
agreed paediatric investigation plan and provide the reasons for such discontinuation 
no less than six months before the disc ontinuation as provided in Article 88;  
(24) the obligation to submit paediatric studies to the Agency or to the Member States, 
including the obligation to enter information on third country clinical trials into the 
European database, as provided for in Art icles 91;  
(25) the obligation to submit to the Agency a paediatric investigation plan with a request 
for agreement or an application for a waiver from it, not later than upon completion 
of the human pharmaco -kinetic studies in adults, except in duly justif ied cases, as 
provided for in Article 76(1).   
EN 1  EN ANNEX III  
PROCEDURE AND CRITERIA GOVERNING INSPECTIONS CARRIED OUT BY 
THE  AGENCY  
Reasoned request by the competent authority  
The supervisory authority may submit after consultation with the Agency, a reasoned request 
to the Agency to carry out an inspection or to participate with its inspectors to an inspection 
carried out of a site located in a third country. The reasoned request should specify:  
– The precise identification of the site, th e scope of the inspections and if relevant the 
concerned products;  
– The timeline for this inspection to be completed;  
– The reasons for requesting the support of the Agency, by reference to the criteria set 
out in this Annex.  
The Agency may refuse an inspect ion request after consideration of the request, the scope and 
availability of internal inspection capacity.  
Assessment by the Agency  
The Agency decides whether it accepts to carry out such inspection or to participate with its 
inspectors in such inspectio n, based on the following criteria:  
– The site is located in a non -EU/EEA country;  
– The inspection is in the interest of the Union, when one or more of the following 
situations apply to ensure faster or continuous access to medicines of patients:  
– to prevent, mitigate or address shortages of medicinal products or their active 
substances or other supply issues;  
– to prevent, mitigate or address a possible threat to public health, a public health 
emergency or a major event which requires immediate action;  
– to addres s a suspicion of non -compliance of the manufacturing site;  
– to enable the process of granting of the marketing authorisation for centrally 
authorised products/emergency use authorisation and for their active substance 
master files;  
– to improve the oversight  of medicines production worldwide;  
– to address serious challenges of an unexpected and temporary nature with 
inspections capacities at national level;  
– other relevant situations.  
The compilation of Union procedures on inspections and exchange of informatio n referred to 
in Article 3(1) of Directive 2017/1572 might be updated to cover rules applicable to situations 
where the Agency may be requested to carry out an inspection or to participate in a joint 
inspection.  
In the context of inspections referred unde r Article 78 of Regulation (EU) 536/2014, the 
above criteria apply mutatis mutandis.   
EN 2  EN ANNEX IV  
AVAILABILITY  
 
Part I  
Information to be provided in case of a suspension or cessation of marketing of a 
medicinal product or withdrawal of the marketing authorisation of a medicinal product  
For the purpose of the notification in accordance with Article 116(1), points (a), (b) and (c), 
the marketing authorisation holder shall notify the following minimum set of information:  
(1) Product details:  
(a) Product name;  
(b) Active substance(s) and active substance supplier(s);  
(c) Finished product manufacturer;  
(d) Anatomical Therapeutic Chemical (ATC)code;  
(e) Therapeutic indication(s);  
(f) Pharmaceutical form;  
(g) Strength(s);  
(h) Route(s) of administration;  
(i) Affected pack size(s);  
(j) Alternative, pharmaceutical form, strength, route of administration or pack 
size, not affected by the suspension, cessation or withdrawal;  
(k) Details of authorisation: procedure type (national (including Member State(s) 
involved)/ centralised marketing authorisation) and reference;  
(l) Member States in which the product is placed on the market.  
 
(2) Details of action (suspension, cessation or withdrawal):  
(a) Category of action (suspension, cess ation or withdrawal);  
(b) Available stock up to start date of action;  
(c) Start date of action, per Member State;  
(d) Reason for action and information on alternative medicinal product(s), where 
relevant;  
(e) Impacted EU/ EEA countries;  
(f) Reference to pending regulatory action, Rapid Alert (quality/ safety) or Quality 
Defect Report related to the action, if relevant;  
(g) Other competent authorities notified;  
(h) Any actions completed or planned based on a request of the competent 
authorities of the Memb er State concerned.  
  
EN 3  EN (3) Contact details  
(a) Marketing authorisation holder name and address;  
(b) Name and contact details of person notifying.  
 
Part II   
Risk assessment of impact of suspension, cessation or withdrawal  
For the purpose of the request made  by the competent authority concerned in accordance with 
Article 118(2), the marketing authorisation holder shall notify at least the following 
information:  
(1) Risk assessment of impact of suspension, cessation or withdrawal, including:  
(a) Potential alte rnative medicinal products;  
(b) Estimated market share per Member State in previous 12 months;  
(c) Quantities delivered per month per Member State in previous 12 months;  
(d) Manufacturing capacity globally per manufacturing site;  
(e) Forecast of supply per month and per Member State until suspension, cessation 
or withdrawal occurs;  
(f) Forecast of demand per month and per Member State in next 6 months;  
(g) Impact on the supply of other medicinal products from the same marketing 
authorisation holder;  
(h) Potential impact on the consumption of or demand for other medicinal 
products.  
(2) Any risk -mitigating measures taken by the marketing authorisation holder to address 
the shortage.  
Part III  
Information to be provided in case of a temporary disruption of su pply (to monitor 
potential or actual shortage)  
For the purpose of the notification in accordance with Article 116(1), point (d) the marketing 
authorisation holder shall notify the following information:  
(1) Product details  
(a) Product name;  
(b) Active sub stance(s) and active substance manufacturer(s);  
(c) Finished product manufacturer;  
(d) Therapeutic indication(s);  
(e) ATC code;  
(f) Pharmaceutical form;  
(g) Strength(s);  
(h) Route(s) of administration;  
(i) Affected pack size;   
EN 4  EN (j) Alternative, pharmaceut ical form, strength, route of administration or pack 
size, not affected by the supply disruption;  
(k) Details of authorisation: procedure type (national (including Member State(s) 
involved)/ centralised marketing authorisation) and reference;  
(l) Member St ates in which the product is placed on the market.  
 
(2) Details of supply disruption  
(a) Shortage status (actual, potential);  
(b) Available stock per month  
(c) Expected start date of shortage by Member State;  
(d) Expected end date of shortage by Member Sta te; 
(e) Reason for shortage;  
(f) Impacted EU/ EEA countries and where available other impacted countries;  
(g) Reference to pending regulatory action, Rapid Alert (quality/ safety) or Quality 
Defect Report related to the action, if relevant;  
(h) Other competent authorities notified;  
(i) Any actions completed or planned based on a request of competent authorities 
of Member State concerned.  
(3) Contact details  
(a) Marketing authorisation holder name and address;  
(b) Name and contact details of person no tifying.  
 
Part IV  
The Shortage Mitigation Plan  
For the purpose of the request made by the competent authority concerned in accordance with 
Article 118(2), the marketing authorisation holder shall notify at least the following 
information:  
1. Shortage mitigation plan, detailing the risk assessment of impact of shortage, 
including, where available:  
(a) Potential alternative medicinal products;  
(b) Estimated market share by Member State in previous 12 months;  
(c) Quantities delivered per month per Membe r State, in previous 12 months;  
(d) Manufacturing capacity globally per manufacturing site;  
(e) Forecast of supply per month and per Member State for the duration of the 
shortage,  
(f) Forecast of demand per month and per Member State for the duration of the 
shortage;   
EN 5  EN (g) Impact on the supply of other medicinal products from the same marketing 
authorisation holder;  
(h) Potential impact on the consumption of or demand for other medicinal 
products;  
(i) Any risk -mitigating measures taken or planned by the mar keting authorisation 
holder to address the shortage.  
 
Part V  
The shortage prevention plan  
The Shortage Prevention Plan referred to in Article 117 shall contain the following minimum 
set of information:  
(1) Product details:  
(a) Product name;  
(b) Active substance(s) and active substance manufacturer(s);  
(c) Finished product manufacturer;  
(d) ATC code;  
(e) Therapeutic indication(s);  
(f) Pharmaceutical form;  
(g) Strength(s);  
(h) Route(s) of administration;  
(i) Pack size(s);  
(j) Details of authorisat ion: procedure type (national (including Member State(s) 
involved)/ centralised marketing authorisation) and reference;  
(k) Member States in which the product is placed on the market.  
(2) Shortage prevention measures and supply chain risk assessment:  
(a) Alternative marketed medicinal products;  
(b) Supply chain map, with risk identification and analysis with particular attention 
to supply chain vulnerabilities;  
(c) Shortage management measures, to include:  
(i) a risk control strategy in place, to include in formation on strategies to 
minimise risks of shortages and how these are implemented;  
(ii) a process for the detection and notification of supply disruptions and  
(iii) a record of root causes of resolved shortages and mitigation measures 
taken for those sh ortages.  
(d) Process for check of effectiveness, review and update of the shortage 
prevention plan.  
(3) Contact details  
(a) Marketing authorisation holder name and address;   
EN 6  EN (b) Name and details of contact person.  
  
EN 7  EN ANNEX V  
CORRELATION TABLE  
 
Regulation (EC) No 
726/2004  Directive 2001/83/EC  Regulation (EC) No 
141/2000  Regulation (EC) No 
1901/2006  This Regulation  
Art. 1     Art. 1  
Art. 2   
Art. 2 Art. 2  Art. 2  
Art. 3(1)     Art. 3(1)  
Art. 3(2), point (b)   
  Art. 3(2), introductory 
sentence and point (a)  
    Art. 3(2), point (b)  
Art. 4(2)     Art. 3( 4) 
Art. 3(3), introductory 
sentence, points (a) and (b)     Art. 4  
Art. 2, 4th subparagraph     Art. 5(1)   
EN 8  EN     Art. 5(2 -7) 
Art. 6(1)     Art. 6(1)  
    Art. 6(2)  
Art. 6(1), 2nd 
subparagraph     Art. 6(3)  
    Art. 6(4) and (5)  
Art. 6(3)     Art. 6(6)  
Art. 14(9)     Art. 6(7)  
Art. 14(9), 1st 
subparagraph, 2nd 
sentence   
  Art. 6(7), 1st subparagraph  
Art. 14(9), 2nd 
subparagraph     Art. 6(7), 2nd 
subparagraph  
    Art. 7  
    Art. 8  
    Art. 9   
EN 9  EN Art. 7   
  Art. 10, paragraph 1, 
points (a) and (b)  
    Art. 10, paragraph 2  
Art. 8(1)     Art. 11(1)  
Art. 8(2), 1st and 2nd 
subparagraph   
  Art. 11(2), 1st and 2nd 
subparagraph  
    Art. 11(2), 3rd 
subparagraph  
Art. 9(1)     Art. 12(1)  
Art. 9(2), 1st subparagraph     Art. 12(2), 1st 
subparagraph  
Art. 62(1), 5th 
subparagraph, 2nd 
sentence   
  Art. 12(2), 2nd 
subparagraph  
Art. 9(2), 2nd 
subparagraph     Art. 12(2), 3rd 
subparagraph  
Art. 9(3)     Art. 12(3)   
EN 10  EN Art. 9(4)     Art. 12(4)  
Art. 14(10)     Art. 12(5)  
Art. 10(1)     Art. 13(1)  
Art. 10     Art. 13 (2-4) 
Art. 11     Art. 14  
Art. 12     Art. 15  
Art. 13     Art. 16  
Art. 14(1)     Art. 17(1)  
Art. 14(2)     Art. 17(2)  
Art. 14(8)     Art. 18  
Art. 14 -a(1)    Art. 19(1)   
EN 11  EN Art. 14-a(3) to (9)   
  Art. 19(2) to (8)  
Art. 10a   
  Art. 20  
Art. 10b     Art. 21  
Art. 14a     Art. 22  
Art. 15     Art. 23  
Art. 14b(1)   
  Art. 24(1), 1st 
subparagraph  
    Art. 24(1), 2nd 
subparagraph  
Art. 14b(2) and (3)     Art. 24(2) and (3)  
    Art. 24(4)  
Art. 82(1)     Art. 25(1), 1st and 2nd 
subparagraph   
EN 12  EN     Art. 25(1), 3rd 
subparagraph  
Art. 82(2) and (3)     Art. 25(2) and (3)  
Art. 83(1)     Art. 26(1)  
    Art. 26(1), 2nd sentence  
Art. 83(2 -3)    Art. 26(2) and (3)  
Art. 83(4), 1st 
subparagraph     Art. 26(4), 1st 
subparagraph  
    Art. 26(4), 2nd to 4th 
subparagraph  
Art. 83(5) to (9)     Art. 26(5) to (9)  
    Art. 26(10)  
Art. 5(3), 1st and 2nd 
sentence     Art. 27, 1st subparagraph   
    Art. 27, 2nd subparagraph   
EN 13  EN Art. 81     Art. 28  
Art. 14(11)     Art. 29  
    Art. 30  
    Art. 31  
    Art. 32  
    Art. 33  
    Art. 34  
    Art. 35  
    Art. 36 
    Art. 37  
    Art. 38  
    Art. 39  
    Art. 40  
    Art. 41   
EN 14  EN     Art. 42  
    Art. 43  
    Art. 44  
Art. 16(1), (2) and (3)     Art. 45(1), (2) and (3)  
Art. 16(3a), 1st 
subparagraph   
  Art. 45(4), 1st 
subparagraph, 1st and 2nd 
sentence  
  
  Art. 45(4), 1st 
subparagraph, 3rd 
sentence  
Art. 16(3a), 2nd 
subparagraph   
  Art. 45(4), 2nd 
subparagraph  
  
  Art. 46  
    Art. 47(1)  
Art. 16a(1)     Art. 47(2)   
EN 15  EN Art. 16a(2)     Art. 47(3), 1st and 2nd 
sentence  
    Art. 47(3), 3rd sentence  
    Art. 47(4), point (a)  
Art. 16(3)     Art. 47(4), points (b)  and 
(c) 
    Art. 47(4), points (d) and 
(e) 
    Art. 48  
Art. 16b     Art. 49  
Art. 18     Art. 50  
Art. 19(1), 1st 
subparagraph     Art. 51(1), 1st 
subparagraph  
    Art. 51(1), 2nd 
subparagraph  
Art. 19(1), 2nd 
subparagraph     Art. 51(1), 3rd 
subparagraph   
EN 16  EN Art. 19(2) and (3)     Art. 51(2) and (3)  
    Art. 52  
    Art. 53  
    Art. 54  
Art. 20     Art. 55  
Art. 20a     Art. 56  
 Art. 127a    Article 57  
  
  Art. 58  
  
  Art. 59  
    Art. 60  
    Art. 61  
    Art. 62   
EN 17  EN   Article 3(1), (a) 1st 
subparagraph and (b)  Art. 63(1)  
    Art. 63(2)  
  Article 3(2)   Art. 63(3)  
  Article 5(1)   Art. 64(1)  
  Article 5(2)   Art. 64(2), 1st 
subparagraph  
    Art. 64(2), 2nd 
subparagraph  
  Article 5(3)  
  Art. 64(3)  
  Article 5( 4) and 5( 5)  Art. 64(4)  
    Art. 64(5)  
  Article 5(11)   Art. 65  
    Art. 66  
  Article 5(9)   Art. 67   
EN 18  EN   
Art. 6(1)   Art. 68(1), introductory 
sentence, point (a)  
    Art. 68(1), points (b) and 
(c) 
  Article 9(1)   Article 68(2)  
  Art. 7   Art. 69  
    Art. 70  
  Art. 8(1)   Art. 71(1)  
    Art. 71(2) to (3) and (5) 
and (6)  
  Art. 8(5)   Art. 71(7)  
   Art. 8(3)   Art. 71(4)  
    Article 72  
  Article 7(2)   Article 73   
EN 19  EN   
 Art. 15(2)  Art. 74(1)  
    Art. 74(2), (3) and (4)  
   Art. 11  Art. 75(1) and (2)  
    Art. 75(3)  
  
 Art. 16  Art. 76(1), (2) and (3)  
    Art. 76(4)  
   Art. 17(1)  and (2)  Art. 77(1)  
    Art. 77(2) to (6)  
   Art. 12  13 14(2) and 14 
(3) Art. 78  
   Art. 14(1)  Art. 79  
   Art. 19  Art. 80  
      
EN 20  EN    Art. 20(1)  Art. 81(1)  and (2)  
  
  Art. 81 (3)  
   Art. 20(2)  Art. 81(4)  
    Art. 82  
  
  Art. 82(3)  
    Art. 83  
   Art. 22, 1st sentence  Art. 84(1), 1st sentence  
    Art. 84(1), 2nd sentence  
    Art. 84(2) and (3)  
   Art. 10  Art. 85(1)  
    Art. 85(2)   
EN 21  EN   
 Art. 23(1)  Art. 86  
  
 Art. 25  Art. 87  
  
  Art. 88  
  
 Art. 26  Art. 89  
  
 Art. 28  Art. 90  
   Art. 46  Art. 91  
    Art. 30  Art. 92  
   Art. 38(1)  Art. 93  
   Art. 41  Art. 94  
   Art. 44  Art. 95   
EN 22  EN    Art. 39(1) and Art. 40 (1) Art. 96  
   Art. 47(1)  Art. 97(1)  
   Art. 47(3)  Art. 97(2)  
   Art. 48  Art. 97(3)  
   Art. 50(1)  Art. 98, introductory 
sentence  
    Art. 98, points (a) to (h)  
Art. 21     Art. 99  
Art. 22     Art. 100  
Art. 24     Art. 101  
Art. 25     Art. 102  
Art. 25a     Art. 103  
Art. 26   
  Art. 104   
EN 23  EN Art. 27     Art. 105  
Art. 28     Art. 106  
Art. 28a     Art. 107 
Art. 28b     Art. 108  
Art. 28c     Art. 109  
Art. 28d     Art. 110  
Art. 28e     Art. 111  
Art. 28f     Art. 112  
    Art. 113  
    Art. 114  
    Art. 115  
    Art. 116  
    Art. 117  
    Art. 118   
EN 24  EN     Art. 119  
    Art. 120  
    Art. 121  
    Art. 122  
    Art. 123  
    Art. 124  
    Art. 125  
    Art. 126  
    Art. 127  
    Art. 128   
EN 25  EN     Art. 129  
    Art. 130  
    Art. 131  
    Art. 132  
    Art. 133  
    Art. 134  
Art. 55     Art. 135  
Art. 71     Art. 136  
Art. 64(2)   
  Art. 136(3)  
Art. 71a     Art. 137 
Art. 57     Art. 138  
Art. 59     Art. 139   
EN 26  EN Art. 58   
  Art. 140  
    Art. 141(1) and (2)  
Art. 77     Art. 141(3)  
Art. 56     Art. 142  
Art. 65     Art. 143  
Art. 66     Art. 144  
Art. 64     Art. 145  
    Art. 146(1)  
Art. 63(1)     Art. 146(2)  
Art. 61     Art. 146(3) to (6)   
EN 27  EN Art. 78(2), 1st sentence     Art. 146(8), 1st 
subparagraph, 1st sentence  
    Art. 146(7)  
  
  Art. 146(8), 1st 
subparagraph, 2nd and 3rd 
sentence  
Art. 78(2), 2nd sentence     Art. 146(8), 2nd 
subparagraph  
    Art. 146(9)  
Art. 63(2)   
  Art. 147  
Art. 5(2)     Art. 148(1)  
Art. 61(5)     Art. 148(2)  
    Art. 148(3)  
Art. 61(2)     148(4)   
EN 28  EN Art. 61(1), 2nd and 3rd 
subparagraph     Art. 148(5)  
    Art. 148(6) and (7)  
Art. 61 (8)     Art. 148 (8)  
Art. 61a(6)     Art. 149(1)  
Art. 61a(1 -4)    Art. 149(2) to (5)  
Art. 56(2), 1st 
subparagraph     Art. 150(1), 1st 
subparagraph  
  
  Art. 150(1), 2nd and 3rd 
subparagraph  
    Art. 150(2) to (5)  
Art. 56(2), 2nd 
subparagraph     Art. 150(6)  
Art. 62(5)     Art. 151(1)   
EN 29  EN Art. 62(2), 1st 
subparagraph     Art. 151(2)  
    Art. 151(3), 1st 
subparagraph  
Art. 62(4), 2nd 
subparagraph     Art. 151(3), 2nd 
subparagraph  
Art. 62(2), 2nd 
subparagraph     Art. 151(4)  
    Art. 151(5), (6) and (7)  
Art. 62(1), 1st 
subparagraph     Art. 152(1), 1st 
subparagraph  
    Art. 152(1), 2nd 
subparagraph  
Art. 62(1), 2nd, 3rd and 
4th subparagraph     Art. 152(1), 3rd to 5th 
subparagraph  
Art. 62(3)     Art. 152(2)  
Art. 67(1 -4)    Art. 152(1 ) and (3 -4) 
Art. 60     Art. 153   
EN 30  EN Art. 67(5)   
  Art. 153(5), 1st 
subparagraph, 1st sentence  
  
  Art. 154  
Art. 67(6 -12)    Art. 154(6) to (12)  
Art. 68     Art. 155  
Art. 69     Art. 156(1) and (2)  
    Art. 156(3) to (6)  
Art. 72     Art. 157  
Art. 73     Art. 158  
Art. 74     Art. 159   
EN 31  EN   
  Art. 160, 1st and 2nd 
subparagraph  
Art. 75, 2nd subparagraph     Art. 160, 3rd subparagraph  
    Art. 161  
    Art. 162  
Art. 78(1)     Art. 163  
    Art. 164  
Art. 80   
  Art. 165, 1st and 2nd 
subparagraph  
    Art. 165, 3rd subparagraph  
    Art. 166  
    Art. 167   
EN 32  EN     Art. 168  
    Art. 169 
    Art. 170  
Art. 84     Art. 171  
Art. 84a     Art. 172  
Art. 87     Art. 173  
Art. 87a, 2nd 
subparagraph     Art. 174(1)  
Art. 87a     Art. 174(2)  
Art. 87b     Art. 175  
    Art. 176  
    Art. 177   
EN 33  EN     Art. 178  
    Art. 179  
  
  Art. 180, 1st and 2nd 
subparagraph  
Art. 90     Art. 181  
ANNEX I (1) to (4)     ANNEX I (1) to (4)  
    ANNEX I (5) and (6)  
ANNEX II     ANNEX II  
    ANNEX III  
    ANNEX IV  
    ANNEX V