1. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall follow the procedure set out in Annex VI.
2. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall:
| (a) | be transparent to Member States, the manufacturer concerned and to other manufacturers or stakeholders that request to be informed |
| (b) | disclose confidential information to the Commission only when necessary to assess the compliance of a European assessment document with regulatory provisions and protect commercial secrecy and confidentiality |
| (c) | specify appropriate mandatory time limits in order to avoid unjustified delay |
| (d) | allow for adequate participation by the Member States and the Commission |
| (e) | be cost-effective for the manufacturer; and |
| (f) | ensure sufficient collegiality and coordination amongst TABs designated for the product in question. |
The balancing of requirements laid down in points (a) and (b) of the first subparagraph shall allow at least for the disclosure of the name of the product at the stage of the approval and the communication of the work programme, as set out in point 3 of Annex VI, and for the disclosure of the detailed contents of the draft European assessment document set out in point 8 of Annex VI.
3. The TABs shall, together with the organisation of TABs, bear the full costs of the development and adoption of European assessment documents, unless such development is initiated by the Commission.
4. TABs and the organisation of TABs shall avoid the proliferation of European assessment documents where there is no technical justification for differentiating between products. They shall, in particular, give preference to extending the scope of existing European assessment documents over creating new European assessment documents.
5. The Commission is empowered to adopt, after consultations with the organisation of TABs, delegated acts in accordance with Article 89 to amend Annex VI in order to add additional procedural rules for the development and adoption of European assessment documents, where it is necessary to ensure the good functioning of the system of European assessment documents.