Transitory Provisions. 1. No later than by 15 July 2019, the Joint Sectoral Committee shall consider whether to include veterinary products within the product coverage of this Annex. The Joint Sectoral Committee shall exchange views on the organisation of the assessment of respective authorities by 15 December 2017. 2. No later than 15 July 2022, the Joint Sectoral Committee shall consider whether to include vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex. Without prejudice to this consider- ation, as of the effective date of this Annex, a Party shall notify the relevant authority of the other Party in advance of conducting a post-approval inspection of a manufacturing facility of such products located in the territory of the Party and give the authority the option of joining the inspection. In order to support the inclusion of vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex, the Joint Sectoral Committee shall take into account, in particular, the experience gained through such joint inspections. 3. No later than 15 July 2019, the Joint Sectoral Committee shall review experience gained in order to decide whether the provisions on pre-approval inspections provided in Article 11 shall be reviewed. 4. Products referred to in paragraphs 1 and 2 shall be included within the product coverage of this Annex only once the Joint Sectoral Committee so decides pursuant to paragraphs 1 and 2. 5. Where the FDA identifies the need for a post-approval inspection of a manufacturing facility in a territory of a Member State authority of which an assessment under this Annex is pending or that the FDA has otherwise not recognized, the FDA shall notify that authority and the EMA in writing. (a) No later than 30 calendar days of the date it receives a notification pursuant to paragraph 5, the authority in whose territory the manufacturing facility is located or EMA on behalf of this authority shall inform the FDA whether it has opted to request a recognized authority of the EU to conduct the inspection and, if so, whether such recognized authority of the EU will conduct the inspection by the date specified in the notification. The authority in whose territory the manufacturing facility is located shall be allowed to join the inspection. ▼M30
Appears in 6 contracts
Sources: Agreement on Mutual Recognition Between the European Community and the United States of America, Agreement on Mutual Recognition Between the European Community and the United States of America, Agreement on Mutual Recognition Between the European Community and the United States of America
Transitory Provisions. 1. No later than by 15 July 2019, the Joint Sectoral Committee shall consider whether to include veterinary products within the product coverage of this Annex. The Joint Sectoral Committee shall exchange views on the organisation of the assessment of respective authorities by 15 December 2017.
2. No later than 15 July 2022, the Joint Sectoral Committee shall consider whether to include vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex. Without prejudice to this consider- ation, as of the effective date of this Annex, a Party shall notify the relevant authority of the other Party in advance of conducting a post-approval inspection of a manufacturing facility of such products located in the territory of the Party and give the authority the option of joining the inspection. In order to support the inclusion of vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex, the Joint Sectoral Committee shall take into account, in particular, the experience gained through such joint inspections.
3. No later than 15 July 2019, the Joint Sectoral Committee shall review experience gained in order to decide whether the provisions on pre-approval inspections provided in Article 11 shall be reviewed.
4. Products referred to in paragraphs 1 and 2 shall be included within the product coverage of this Annex only once the Joint Sectoral Committee so decides pursuant to paragraphs 1 and 2.
5. Where the FDA identifies the need for a post-approval inspection of a manufacturing facility in a territory of a Member State authority of which an assessment under this Annex is pending or that the FDA has otherwise not recognized, the FDA shall notify that authority and the EMA in writing.
(a) No later than 30 calendar days of the date it receives a notification pursuant to paragraph 5, the authority in whose territory the manufacturing facility is located or EMA on behalf of this authority shall inform the FDA whether it has opted to request a recognized authority of the EU to conduct the inspection and, if so, whether such recognized authority of the EU will conduct the inspection by the date specified in the notification. The authority in whose territory the manufacturing facility is located shall be allowed to join the inspection. ▼M30.
Appears in 3 contracts
Sources: Agreement on Mutual Recognition Between the European Community and the United States of America, Agreement on Mutual Recognition Between the European Community and the United States of America, Agreement on Mutual Recognition Between the European Community and the United States of America
Transitory Provisions. 1. No later than by 15 July 201912 months following the entry into force of this Agreement, the Joint Sectoral Committee of the Authorities shall review experience gained, including timelines for sharing GMP documents, in order to consider whether to include veterinary products within the product coverage of provisions on pre- and post-approval inspections provided in this AnnexAgreement shall be reviewed. The Joint Sectoral Committee shall exchange views on the organisation of the assessment of respective authorities by 15 December 2017Authorities may decide to postpone this review.
2. No later than 15 July 2022three years following the entry into force of this Agreement, the Joint Sectoral Committee of the Authorities shall consider whether to include vaccines for human use and plasma derived pharmaceuticals within the product coverage of this AnnexAgreement.
3. Without prejudice to this consider- ationthe consideration identified in paragraph 1 and 2, as of the effective entry into force date of this AnnexAgreement, a Party an Authority shall notify the relevant authority Authority of the other Party in advance of conducting a pre-approval, post-approval approval, or GMP inspection of a manufacturing facility of such products vaccines for human use located in the territory of the Party and give the authority Authority of that Party the option of joining the inspection. In order to support the inclusion of vaccines for human use and plasma derived pharmaceuticals within the product coverage of this AnnexAgreement, the Joint Sectoral Committee of the Authorities shall take into account, in particular, the experience gained through such joint inspections.
3. No later than 15 July 2019, the Joint Sectoral Committee shall review experience gained in order to decide whether the provisions on pre-approval inspections provided in Article 11 shall be reviewed.
4. Products referred Either at the time of the initial consideration identified in paragraph 2, or thereafter, the Joint Committee of the Authorities may decide to in paragraphs 1 and 2 shall be included include vaccines for human use within the product coverage of this Annex only once Agreement. If the Joint Sectoral Committee so decides pursuant of the Authorities makes such a decision, it will promptly refer the matter to paragraphs 1 and 2the Joint Committee of the Parties with a view to amend Annex 2 in accordance with Article 17.
5. Where In the FDA identifies the need for a post-approval inspection of a manufacturing facility in a territory of a Member State authority of which an assessment under this event that Annex 2 is pending or that the FDA has otherwise not recognized, the FDA shall notify that authority and the EMA in writing.
(a) No later than 30 calendar days of the date it receives a notification amended pursuant to paragraph 54, the authority respective Authorities shall, without undue delay, make the amended text publicly available on their respective websites.
1. Each Party shall notify the other Party of a change to its laws related to this Agreement, including those laws listed in whose territory Annex 1, as soon as practicable. Annex 1 shall be amended accordingly, if necessary.
2. Each Party shall notify the manufacturing facility is located other Party of a change to its regulations related to this Agreement, including those regulations listed in Annex 1, at least 60 days before the change enters into force. If considerations of safety, health, or EMA on behalf of this authority environmental protection require more urgent action, the Party shall inform notify the FDA whether it has opted to request a recognized authority other Party of the EU to conduct the inspection andchange as soon as practicable. Annex 1 shall be amended accordingly, if so, whether such recognized authority necessary.
3. Each Party shall notify the other Party of any significant changes that may have an impact on the EU will conduct the inspection by the date specified in the notification. The authority in whose territory the manufacturing facility is located shall be allowed to join the inspection. ▼M30criteria for recognition as soon as practicable.
Appears in 2 contracts
Sources: Agreement on Mutual Recognition, Mutual Recognition Agreement
Transitory Provisions. 1. No later than by 15 July 2019, the Joint Sectoral Committee shall consider whether to include veterinary products within the product coverage of this Annex. The Joint Sectoral Committee shall exchange views on the organisation of the assessment of respective authorities by 15 December 2017.
2. No later than 15 July 2022, the Joint Sectoral Committee shall consider whether to include vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex. Without prejudice to this consider- ation, as of the effective date of this Annex, a Party shall notify the relevant authority of the other Party in advance of conducting a post-approval inspection of a manufacturing facility of such products located in the territory of the Party and give the authority the option of joining the inspection. In order to support the inclusion of vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex, the Joint Sectoral Committee shall take into account, in particular, the experience gained through such joint inspectionsinspec- tions.
3. No later than 15 July 2019, the Joint Sectoral Committee shall review experience gained in order to decide whether the provisions on pre-approval inspections provided in Article 11 shall be reviewed.
4. Products referred to in paragraphs 1 and 2 shall be included within the product coverage of this Annex only once the Joint Sectoral Committee so decides pursuant to paragraphs 1 and 2.
5. Where the FDA identifies the need for a post-approval inspection of a manufacturing facility in a territory of a Member State authority of which an assessment under this Annex is pending or that the FDA has otherwise not recognized, the FDA shall notify that authority and the EMA in writing.
(a) No later than 30 calendar days of the date it receives a notification pursuant to paragraph 5, the authority in whose territory the manufacturing facility is located or EMA on behalf of this authority shall inform the FDA whether it has opted to request a recognized authority of the EU to conduct the inspection and, if so, whether such recognized authority of the EU will conduct the inspection by the date specified in the notification. The authority in whose territory the manufacturing facility is located shall be allowed to join the inspection. ▼M30
Appears in 1 contract
Sources: Agreement on Mutual Recognition Between the European Community and the United States of America