Each Party shall notify the other Party of changes to technical regulations related to the subject matter of this Agreement at least 90 days before their entry into force.

to continue to achieve compliance with regulatory targets and deadlines for post authorisation issues under the centralised system

This will contribute significantly to achieving full compliance with regulatory deadlines laid down in Community law, which to date has been complied with.

This will allow the exploitation of all species in the group if toxin levels in the indicator species are below the regulatory limits.

To ensure that consistency of all MRL status and summary reports for new applications and old substances is maintained fully according to quality control standards established previously (ongoing)

to continue to achieve compliance with regulatory targets and deadlines for scientific opinions for marketing authorisation applications under the centralised system

a description of the conformity assessment services that the technical service undertakes in the framework of the relevant regulatory acts and a list of the regulatory acts for which the technical service applies for designation, including limits of capability, where applicable

Regulatory action

September 20 23 October 18 21 November 15 18 December 13 16

(Statutory plates)

Addressing regulatory challenges.

Regulatory affairs

If a Party deems that information it receives must be translated into its official language or languages, that Party shall undertake the necessary translation and bear the cost.

LSA Code refers to the International Life Saving Appliance Code adopted on 4 June 1996 (IMO Resolution MSC.48(66)). Recommendation on Testing refers to the IMO recommendation on Testing of Life Saving Appliances adopted on 6 November 1991 (IMO Resolution A.689(17)) as amended on 11 December 1998 (IMO Resolution MSC.81(70).

Regulatory matters

Regulatory initiatives

Time limits

Good regulatory practices

Safety and efficacy of medicines

countries and European institutions.

Administration

Hans Wagner

2.3 Regulatory Constraints

3.4 Regulatory constraints

3.8 Regulatory constraints

Time limits

the supply of a service through the presence of a natural person of the other Party in the territory of the Party, in accordance with Article 10.6.2 (Obligations in other chapters).

4.12 The Committee could suggest a combination of legislative and non legislative measures

to continue to achieve 100 compliance with regulatory deadlines for completion of marketing authorisation applications and variations under the centralised system (throughout 1998)

Legislative provisions and regulations

Head of Unit Regulatory affairs and pharmacovigilance

Administrative amp regulatory issues

Regulatory affairs and pharmacovigilance

CHAPTER 4

locally established enterprise means a juridical person that is constituted or organised under the laws of the respondent and that an investor of the other Party owns or controls directly or indirectly

Notwithstanding Articles 20.19.2 and 20.19.3, the protection of the geographical indications listed in Part A of Annex 20 A and identified by two asterisks shall not prevent the use of this indication by any persons, including their successors and assignees, who made commercial use of this indication with regard to products in the class of fresh, frozen and processed meats for at least five years preceding the date of 18 October 2013.

Policy Regulatory

Interested parties

Part B Regulatory affairs pharmacovigilance Total human resources

EMEA Management Board

(2) Use of regulatory instruments (a Recommendation)

(d) regulatory own funds

10.5 Concerning regulatory restrictions

3.6 Harmonisation of the rules.

3.7.2 Rules harmonisation.