(1)

In order to avoid undue variability in capital requirements across institutions, and to make the mandate-based approach operational in situations where there is insufficient information, it is necessary to specify the method for calculating the risk-weighted exposure amount for a collective investment undertaking (CIU) under the mandate-based approach for the cases where missing inputs do not allow for the computation of the risk weighted exposure amount.

(2)

Where a CIU enters into derivative transactions and the underlyings of the derivatives or the underlying risk of the derivatives’ positions are unknown, the replacement cost of the positions cannot be determined by institutions, therefore neither can their exposure value. In that case, institutions should base their calculations on the notional amount of a derivative’s position, which would usually be known and would be the best indicator of the size of the position, therefore providing an approximation for the exposure value.

(3)

Where the CIU’s mandate does not exclude entering into derivatives but does not include sufficient information to determine whether an underlying constitutes an on- or off-balance sheet exposure, it cannot be excluded that such an exposure is constituted. It is therefore necessary to include that exposure in the calculation of the risk-weighted exposure amounts of the CIU’s exposures.

(4)

Where the mandate does not provide sufficient information about the exposure value of such position, it cannot be excluded that the exposure value is the full notional amount of the derivative position.

(5)

Where the mandate does not specify the notional amount of the derivative position, to ensure a sufficiently prudent approach, that amount should be derived from the maximum notional amount of derivatives allowed under the mandate.

(6)

Where the replacement costs or the potential future exposure for the purposes of calculating the exposure amount associated with counterparty credit risk are unknown, institutions should base their calculations on the sum of notional amounts of the transactions in the netting set, which would be the best available conservative estimate to allow for the use of the mandate-based approach.

(7)

There are cases in which it is not possible for institutions to ascertain the relevant netting sets for a certain type of derivative in the CIU, since there is no information available on the counterparties or on whether the transactions are subject to a legally enforceable bilateral netting arrangement referred to in Article 272, point (4), of Regulation (EU) No 575/2013. In those cases, institutions should assume that neither netting effects nor counterparty diversification exist for that type of derivative. Therefore, institutions should assume that the CIU has entered into a single derivative with the maximum notional amount allowed by the mandate for that type of derivative.

(8)

This Regulation is based on the draft regulatory technical standards submitted to the Commission by the European Banking Authority.

(9)

The European Banking Authority has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the advice of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (2),

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, the application from Italy for approval of a non-minor amendment to the product specification of the Protected Geographical Indication ‘Aceto Balsamico di Modena’ was published in the Official Journal of the European Union (2).

(2)

On 31 August 2021 the Commission received from Germany three notices of opposition and one reasoned statement. Two other reasoned statements of opposition from Germany were submitted on 11 October 2021. On 16 September 2021 the Commission received the fourth notice of opposition from an opponent based in Türkiye. The related reasoned statement of opposition was submitted on 16 November 2021.

(3)

After examining the reasoned statements of opposition and founding them admissible, in accordance with Article 51(3) of Regulation (EU) No 1151/2012, the Commission, by letter of 10 December 2021, invited both Italy and Germany and Italy and the opponent from Türkiye to engage in appropriate consultations in view of reaching an agreement.

(4)

On 4 March 2021 Germany informed the Commission that one of the oppositions was withdrawn, but maintained by two other opponents from Germany.

(5)

The consultations between Italy and Germany on one side and Italy and the opponent from Türkiye on the other ended without an agreement being reached. The Commission should therefore take a decision on the amendments in accordance with the procedure provided for in Article 52(3)(b) of Regulation (EU) No 1151/2012 taking into account the results of these consultations.

(6)

The opponents considered that the amendments to the product specification would result in non-compliance with the conditions laid down in Article 5(2) of Regulation (EU) No 1151/2012, notably for breaking the link between the product and the geographical area. To that end, alleged changes to the organoleptic characteristics of ‘Aceto Balsamico di Modena’, the change of the minimum total acidity for the aged product and a correction procedure for possible deviations from the parameters were questioned. These amendments were also contested as lowering the quality of ‘Aceto Balsamico di Modena’ and resulting in non-compliance with the requirements laid down for wine vinegars under point 17 of Part II of Annex VII to Regulation (EU) No 1308/2013 of the European Parliament and of the Council (3) establishing a common organisation of the markets in agricultural products (acidity of at least 60 grams per litre = at least 6 %).

(7)

Moreover, the opponents alleged non-compliance with the minimum requirements for the content of the product specification, with regard to Article (7)(1)(g) of Regulation (EU) No 1151/2012, concerning the removal of indication of the control body for ‘Aceto Balsamico di Modena’.

(8)

Furthermore, the opponents alleged that the existing scope of protection has been unduly extended and, thus, the registration of the amendments would jeopardise the existence of names, trade marks or products, including balsamic vinegars of other origins. This claim would, in particular, concern the alleged inclusion of the obligation of bottling in the demarcated area, an additional rule on shape of containers, as well as the introduction of isotopic ratio parameters. As a result, the opponents claim that the planned amendments allegedly prejudice the interests of the bottlers of ‘Aceto Balsamico di Modena’ and German producers of other vinegars.

(9)

Finally, the opponents claimed that newly introduced reduction of minimum acidity could lead to confusion between ‘Aceto Balsamico di Modena’ PGI and ‘Aceto Balsamico Tradizionale di Modena’ PDO.

(10)

The Commission has assessed the arguments exposed in the reasoned statements of opposition from Germany and Türkiye in the light of the provisions of Regulation (EU) No 1151/2012, taking into account the results of the appropriate consultations carried out between the applicant and the opponents and it has concluded that the amendment to the product specification for the protected geographical indication ‘Aceto Balsamico di Modena’ should be approved.

(11)

Italy claimed that the opponents had not demonstrated their legitimate interest in lodging the oppositions, as required by Article 51(1) of Regulation (EU) No 1151/2012, since the opponents contested amendments that were either not applied for or that did not result in trade and/or market barriers.

In the context of the procedure applicable to applications for amendments to the specification that are not minor, any natural or legal person having a legitimate interest may lodge an opposition to the application for amendment submitted. In the present case, the risk of harm to the interests of the opponents was not considered as purely improbable, nor hypothetical and, therefore, it was concluded that the opponents demonstrated legitimate interest in lodging the oppositions.

(12)

The analysis of the reservations submitted by the opponents revealed that indeed some of the claims were made with regard to the elements in the product specification that in fact have not changed as a result of the present amendments, but that consisted of mere editorial changes. These editorial changes aimed at bringing the single document in line with Article 8(1)(c) of Regulation (EU) No 1151/2012 and better reflecting the conditions established in the product specification of ‘Aceto Balsamico di Modena’ PGI. This concerns, in particular, the alleged changes to the organoleptic characteristics, the alleged changes concerning the use of additives and the use of plastic containers, as well as alleged obligation of bottling in the demarcated area. These rules have not changed, while the rewording that appeared in the single document and might have been perceived as amendments to the product specification, in fact resulted from the rectification of discrepancies between the product specification and the summary of the product specification that was published the Official Journal of the European Union (4). The Commission’s assessment of the application for amendment of ‘Aceto Balsamico di Modena’ PGI has focussed on the substantial amendments applied for.

(13)

The changes concerning a minimum percentage of acidity for the ‘invecchiato’ (aged) type from 6 % to 5,5 % or allowed correction procedure for possible deviations cannot be considered as negatively impacting the link between the product and its geographical origin. The reasons behind these amendments have been explained and duly justified in the publication of the application, while it is evident that the nature and scale of these amendments do not alter the essential characteristics of ‘Aceto Balsamico di Modena’ PGI and consequently cannot make the link disappear.

(14)

Moreover, the similarity in the level of acidity does not have a capacity to create confusion between ‘Aceto Balsamico di Modena’ PGI and ‘Aceto Balsamico Tradizionale di Modena’ PDO or lead to the evocation of the latter. Even if products under both designations share certain characteristics, like the level of acidity, they are made of different raw materials and follow different production method and thus remain distinct.

(15)

Finally, ‘Aceto Balsamico di Modena’ PGI is not defined as a wine vinegar and thus not subject to the rules applicable to wine vinegars, in particular with regard to the minimum acidity.

(16)

With respect to the oppositions concerning the extension of the size range of the bottles, the amendment cannot be considered as imposing any limitations on the operators involved in packaging of ‘Aceto Balsamico di Modena’. On the contrary, allowing additional capacities of containers such as 0,100 l, 0,150 l, 0,200 l or 1,5 l can be considered as liberalising the conditions for bottling. A possible effect of an increased competition that might result from the marketing of ‘Aceto Balsamico di Modena’ in a wider range of bottle sizes would be in line with the founding principles of the EU competition policy and should not be considered as detrimental to the reputation of the ‘Aceto Balsamico di Modena’ PGI.

(17)

The aim of the characteristics of the containers with a capacity of less than 0,250 litres included in section 3.5 of the single document is to ensure a minimum standard of uniformity among the bottles, in which the product will be sold. This packaging rule is not included in the description of the product, nor is elaborated with regard to the product specificity under the section of the single document devoted to the link and thus it cannot be considered as an essential feature of the presentation of the product. As these requirements are set only for new containers with a capacity of less than 0,250 litres, which were not allowed before the present amendment, the contested change will not negatively impact investments in containers already made by the bottlers of ‘Aceto Balsamico di Modena’ and consequently, it will not result in their economic loss.

(18)

Information regarding the control body has not been provided directly in the single document, as it is not required there in line with Annex I to Commission Implementing Regulation (EU) No 668/2014 (5). However, this information has been included in the product specification, as stipulated in Article 7(1)(g) of Regulation (EU) No 1151/2012.

(19)

With reference to the opponents’ objections to the required compliance with the isotopic ratio parameters, such parameters have been introduced to better detect possible adulteration of the wine vinegar and improve the control system for ‘Aceto Balsamico di Modena’. The verification of the isotopic ratio is in any event carried out at the production stage and thus affecting only producers of ‘Aceto Balsamico di Modena’.

(20)

Accordingly, the amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Aceto Balsamico di Modena’ (PGI) should be approved.

(21)

The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee,

(1)

Regulation (EU) 2016/429 lays down, inter alia, the animal health requirements for the entry into the Union of consignments of animals, germinal products and products of animal origin, and it applies from 21 April 2021. One of those animal health requirements is that those consignments must come from a third country or territory, or zone or compartment thereof listed in accordance with Article 230(1) of that Regulation.

(2)

Commission Delegated Regulation (EU) 2020/692 (2) supplements Regulation (EU) 2016/429 as regards the animal health requirements for the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories, or zones or compartments thereof. Delegated Regulation (EU) 2020/692 provides that consignments of animals, germinal products and products of animal origin falling within its scope may only be permitted to enter into the Union if they come from a third country or territory, or zone or compartment thereof, listed for the particular species and categories of animals, germinal products and products of animal origin, in accordance with the animal health requirements laid down in that Delegated Regulation.

(3)

Commission Implementing Regulation (EU) 2021/404 (3) lays down the lists of third countries or territories, or zones or compartments thereof, from which the entry into the Union of those species and categories of animals, germinal products and products of animal origin, that fall within the scope of Delegated Regulation (EU) 2020/692, is permitted. The lists and certain general rules concerning the lists are set out in Annexes I to XXII to that Implementing Regulation.

(4)

Annex XV, Part 1 to Implementing Regulation (EU) 2021/404 sets out the list of third countries or territories, or zones thereof, authorised for entry into the Union of meat products from ungulates, poultry and game birds. Annex XIX, Part 1 to Implementing Regulation (EU) 2021/404 sets out the list of third countries or territories, or zones thereof, authorised for entry into the Union of consignments of eggs and egg products.

(5)

Moldova has submitted an application to the Commission to be authorised for the entry into the Union of consignments of meat products of poultry other than ratites, and eggs, and provided guarantees regarding compliance, by that third country, with the requirements on the notification and reporting of the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for poultry, and guarantees regarding compliance by that third country with the relevant Union animal health requirements or with equivalent requirements. Therefore, and taking into account the poultry health situation in Moldova, it is appropriate to include that third country in the lists set out in Annex XV, Part 1 and in Annex XIX, Part 1 to Implementing Regulation (EU) 2021/404 as regards meat products of poultry other than ratites and eggs.

(6)

Annexes XV and XIX to Implementing Regulation (EU) 2021/404 should therefore be amended accordingly.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Commission Delegated Regulation (EU) 2022/2292 (2) supplements Regulation (EU) 2017/625 and aims to ensure that consignments of food-producing animals and certain goods intended for human consumption from third countries or regions thereof comply with certain Union food safety requirements or those recognised to be at least equivalent thereto. In particular, that Regulation identifies the animals and goods intended for human consumption that are subject to the requirement to come from a third country or region thereof which appears on the list referred to in Article 126(2)(a) of Regulation (EU) 2017/625.

(2)

Article 7 of Delegated Regulation (EU) 2022/2292 provides that certain consignments of food-producing animals, products of animal origin and composite products are to enter the Union only from a third country included in the list of third countries approved for the entry into the Union of such consignments for human consumption.

(3)

Commission Implementing Regulation (EU) 2021/405 (3) lays down a list of third countries or regions thereof authorised for the entry into the Union of consignments of certain highly refined products, intended for human consumption.

(4)

Since a recent amendment (4) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (5), highly refined products also cover fat derivatives and food flavourings that are authorized in accordance with Regulation (EC) No 1334/2008 of the European Parliament and of the Council (6), subject to treatments excluding any public or animal health risk. Implementing Regulation (EU) 2021/405 should be amended to be consistent with this change.

(5)

Azerbaijan has submitted a control plan, which covers roes and caviar. The plan provides sufficient guarantees and should therefore be approved.

(6)

Lebanon has submitted a control plan, which covers honey. The plan provides sufficient guarantees and should therefore be approved.

(7)

Isle of Man is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for its export to the Union of ovine and caprine meat. However, Isle of Man has informed the Commission that it is no longer interested in exporting caprine meat to the Union. The entry for Isle of Man for ovine and caprine meat in that table of Annex -I to Implementing Regulation (EU) 2021/405 should therefore only cover ovine meat.

(8)

Japan is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for their export to the Union of pork meat. However, Japan has informed the Commission that it is no longer interested in submitting a control plan for pork meat but intends to use only pork meat originating either from Member States or third countries from which such products are authorised for entry into the Union. Consequently, the entry for Japan for pork meat should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405.

(9)

The United Kingdom is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for their export to the Union of rabbit meat. However, the United Kingdom has informed the Commission that it is no longer interested to submit a control plan for rabbit meat but intends to use only rabbit meat originating either from Member States or third countries from which such products are authorised for entry into the Union. Consequently, the entry for United Kingdom for rabbit meat should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405.

(10)

Thailand has not submitted to the Commission a control plan for milk. However, Thailand has provided guarantees to use only milk originating either from Member States or third countries from which milk is authorised for entry into the Union. It has also informed the Commission that such milk to be exported to the Union will not be limited to composite products containing processed milk products. Consequently, the entry for Thailand for milk should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405.

(11)

The United States of America has submitted a control plan, which covers casings. The plan provides sufficient guarantees and should therefore be approved.

(12)

Rwanda is currently listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for honey and Colombia and Syria are listed for casings. As those third countries have not submitted to the Commission plans for the respective products, those entries should be deleted from the table in that Annex.

(13)

Moldova submitted a Salmonella control programme in flocks of laying hens in order to be authorised for the entry into the Union of class A eggs in accordance with Article 7 of Implementing Regulation (EU) 2021/405. That control programme was assessed with satisfaction by the Commission. The compliance related to the requirements on Salmonella control in accordance with Article 10(6) of Regulation (EC) No 2160/2003 of the European Parliament and of the Council (7) was double checked during the audit carried out by the Commission in April 2022 (8). Moldova should therefore be authorised for the entry into the Union of class A eggs.

(14)

Implementing Regulation (EU) 2021/405 should therefore be amended accordingly.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Commission Directive 2008/107/EC (2) included abamectin as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance abamectin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2023.

(4)

An application for the renewal of the approval of the active substance abamectin was submitted to Austria, the rapporteur Member State, and Malta, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 17 April 2019. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of abamectin.

(7)

The Authority communicated the draft renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 15 July 2020, the Authority communicated to the Commission its conclusion (6) on whether abamectin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority identified a number of issues that could not be finalised. In particular it identified risks as regards birds and mammals, aquatic organisms and soil macroorganisms.

(9)

On 1 February 2022, the Commission sent a mandate to the Authority with a request to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The Authority sent to the Commission an updated conclusion on 27 July 2022 (7). In its updated Conclusion, the Authority confirmed the risks identified in the previous assessment.

(10)

The Commission presented a renewal report and the draft Regulation for abamectin to the Standing Committee on Plants, Animals, Food and Feed, on 25 March 2021 and revised versions of the two documents on 8 December 2022 to take into account the outcomes in the updated Conclusion of the Authority.

(11)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments on both versions of the renewal report, which have been carefully examined.

(12)

It has been established with respect to one or more representative uses of at least one plant protection product containing abamectin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(13)

The risk assessment for the renewal of the approval of the active substance abamectin is based on representative uses as insecticide and acaricide in protected crops. While it is not necessary, in the light of this risk assessment, to maintain the restriction to use only as insecticide and acaricide, it is necessary to provide, in accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, for certain conditions and restrictions. It is, in particular, appropriate to restrict the use of plant protection products containing abamectin to uses which allow controlled exchange of material and energy with the surroundings, so as to prevent the release of plant protection products into the environment and mitigate the high risk identified to aquatic organisms and wild terrestrial non-target organisms. Accordingly, uses in permanent greenhouses may be authorised.

(14)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(15)

Commission Implementing Regulation (EU) 2022/378 (8) extended the approval period of abamectin to 30 April 2023 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. Given that a decision on renewal has been taken ahead of that extended expiry date, and taking into account that the current approval of abamectin expires on 30 April 2023, this Regulation should enter into force as soon as possible and apply earlier then that date.

(16)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Commission Implementing Regulation (EU) 2020/2236 (3) sets out the model animal health certificates for the entry into the Union and movements within the Union of consignments of aquatic animals and of certain products of animal origin from aquatic animals.

(2)

In particular, Annex II to Implementing Regulation (EU) 2020/2236 sets out the model animal health certificate for the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption (model ‘AQUA-ENTRY-ESTAB/RELEASE/OTHER’). Article 166 of Commission Delegated Regulation (EU) 2020/692 (4) was recently amended by Delegated Regulation (EU) 2023/119 (5) in order to permit aquatic animal health professionals to perform clinical inspections on consignments of aquatic animals prior to export to the Union, provided they are authorised to do so under the law of the exporting third country or territory. Those new requirements for the entry into the Union of those consignments should be reflected in point II.3.2. of that model animal health certificate. Annex II to Implementing Regulation (EU) 2020/2236 should therefore be amended accordingly.

(3)

In order to avoid any disruption to trade as regards the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption, the use of animal health certificate issued in accordance with Implementing Regulation (EU) 2020/2236, as applicable prior to the amendments made by this Implementing Regulation, should continue to be authorised during a transitional period subject to certain conditions.

(4)

As Implementing Regulation (EU) 2020/2236 applies from 21 April 2021, in the interest of legal certainty and to facilitate trade, the amendments to be made to Implementing Regulation (EU) 2020/2236 by this Regulation should take effect as a matter of urgency.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

1.

‘(a)

preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products and on medical devices at Union level;’,

‘(a)

preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products at Union level;’.

2.

3.

4.

5.

‘(d)

request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6) on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.’,

‘(d)

request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6), second subparagraph, on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.’.

6.

7.

‘(a)

submit the set of information referred to in Article 6(4) including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6) and using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;’,

‘(a)

submit the set of information referred to in Article 9(2), point (d), including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6), second subparagraph, using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;’.

8.

9.

‘(b)

Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(1), point (d), in accordance with Articles 9 and 11.’,

‘(b)

Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 3(6), second subparagraph, in accordance with Articles 9 and 11.’.

10.

‘(b)

Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 9(1), point (e).’,

‘(b)

Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 3(6), second subparagraph.’.

11.

12.

13.

14.

‘(a)

submit the set of information referred to in Article 22(2), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 25(2), point (a), and using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);’,

‘(a)

submit the set of information referred to in Article 25(2), point (d), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 21(5), second subparagraph, using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);’.

15.

16.

‘(b)

take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);’,

‘(b)

take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 28, point (a);’.

(1)

in Table “A. Natural persons referred to in Article 2(1)”, entries 10, 17, 20, 22, 35, 39, 41, 42, 64, 65, 71, 73, 75, 78, 85, 87, 89, 90, 123, 125 and 179 are replaced by the following:’,

(1)

in Table “A. Natural persons referred to in Article 2(1)”, entries 10, 17, 20, 22, 35, 39, 41, 42, 64, 65, 71, 73, 75, 78, 85, 87, 89, 90, 104, 123, 125, 129, 131, 179 and 195 are replaced by the following:’.