AGREEMENT ON MUTUAL RECOGNITION 

BETWEEN THE UNITED STATES OF AMERICA AND 

THE UNITED KINGDOM OF GREAT BRITAIN AND 

NORTHERN IRELAND 
TABLE OF CONTENTS 

1. Framework 2 

2. Telecommunications Equipment 17 

3. Electromagnetic Compatibility (EMC) 29 

4. Pharmaceutical Good Manufacturing Practices (GMPs) 39 

1 
AGREEMENT ON MUTUAL RECOGNITION 

BETWEEN THE UNITED STATES OF AMERICA AND 

THE UNITED KINGDOM OF GREAT BRITAIN AND 

NORTHERN IRELAND 

The United States of America ("the United States") and the United Kingdom of Great 

Britain and Northern Ireland ("the United Kingdom"), hereafter referred to as "the 

Parties", 

CONSIDERING the traditional links of friendship that exist between the United 

States and the United Kingdom; 

DESIRING to facilitate bilateral trade between them; 

RECOGNIZING that mutual recognition of conformity assessment activities can be 

an important means of enhancing market access between the United States and the 

United Kingdom; 

RECOGNIZING that an agreement providing for mutual recognition of conformity 

assessment activities is of particular interest to small and medium-sized businesses in 

the United States and the United Kingdom; 

RECOGNIZING that any such mutual recognition also requires confidence in the 

continued reliability of the conformity assessments of the United States and the 

United Kingdom; 

RECOGNIZING the importance of maintaining the high levels of health, safety, 

environmental, and consumer protection in the United States and the United 

Kingdom; 

RECOGNIZING that mutual recognition agreements can positively contribute to the 

facilitation of bilateral trade; 

NOTING that this Agreement is not intended to displace private sector bilateral and 

multilateral arrangements among conformity assessment bodies or to affect regulatory 

regimes allowing for manufacturers' self-assessments and declarations of conformity; 

2 
BEARING IN MIND that the Agreement on Technical Barriers to Trade, an 

agreement annexed to the Agreement Establishing the World Trade Organization 

(WTO), encourages WTO Members to enter into negotiations for the conclusion of 

agreements for the mutual recognition of results of each other's conformity 

assessment procedures; 

RECOGNIZING that any such mutual recognition needs to offer an assurance of 

conformity with applicable technical regulations or standards equivalent to the 

assurance offered by the Party's own procedures; 

RECOGNIZING the need to conclude an Agreement on Mutual Recognition (MRA) 

in the field of conformity assessment with sectoral annexes; and 

BEARING IN MIND the respective commitments of the Parties under bilateral, 

regional, and multilateral environment, health, safety, and consumer protection 

agreements, 

HAVE AGREED AS FOLLOWS: 

ARTICLE 1 

Definitions 

1. The following terms and definitions shall apply to this Agreement only: 

Designating Authority means a body with power to designate, monitor, 

suspend, remove suspension of, or withdraw conformity assessment 

bodies as specified under this Agreement. 

Designation means the identification by a Designating Authority of a 

conformity assessment body to perform conformity assessment 

procedures under this Agreement. 

Party means the United States or the United Kingdom, as the case may be. 

Regulatory Authority means a government agency or entity that 

exercises a legal right to control the use or sale of products within a 

Party's jurisdiction, and may take enforcement action to ensure that 

products marketed within its jurisdiction comply with legal requirements. 

3 
2. Other terms concerning conformity assessment used in this Agreement shall 

have the meaning given elsewhere in this Agreement or in the definitions contained in 

International Organization for Standardization (ISO) and the International 

Electrotechnical Commission (IEC) ISO/IEC 17000:2004 and ISO/IEC Guide 2:2004. 

In the event of an inconsistency between ISO/IEC 17000:2004, ISO/IEC Guide 

2:2004, and definitions in this Agreement, the definitions in this Agreement shall 

prevail. 

ARTICLE2 

Purpose of the Agreement 

This Agreement specifies the conditions by which each Party shall accept or 

recognize results of conformity assessment procedures, produced by the conformity 

assessment bodies or authorities of the other Party, in assessing conformity to an 

importing Party's requirements, as specified on a sector-specific basis in the Sectoral 

Annexes, and to provide for other related cooperative activities. The objective of 

such mutual recognition is to provide effective market access between the United 

States and the United Kingdom with regard to conformity assessment for all products 

covered under this Agreement. If any obstacles to such access arise, consultations 

will promptly be held. In the absence of a satisfactory outcome of such consultations, 

the Party alleging its market access has been denied, may, within 90 days of such 

consultation, invoke its right to terminate this Agreement in its entirety, or any 

individual Sectoral Annex thereof, in accordance with Article 20. 

ARTICLE3 

General Obligations 

1. The United States shall, as specified in the Sectoral Annexes, accept or 

recognize results of specified procedures, used in assessing conformity to specified 

legislative, regulatory, and administrative provisions of the United States, produced 

by designated conformity assessment bodies and/or authorities in the United 

Kingdom. 

2. The United Kingdom shall, as specified in the Sectoral Annexes, accept or 

recognize results of specified procedures, used in assessing conformity to specified 

legislative, regulatory, and administrative provisions of the United Kingdom, 

produced by designated conformity assessment bodies and/or authorities in the United 

States. 

4 
3. Where sectoral transition arrangements have been specified in Sectoral 

Annexes, the above obligations will apply following the successful completion of 

those sectoral transition arrangements, with the understanding that the conformity 

assessment procedures utilized assure conformity to the satisfaction of the importing 

Party with applicable legislative, regulatory, and administrative provisions of that 

Party, equivalent to the assurance offered by the importing Party's own procedures. 

ARTICLE4 

General Coverage of the Agreement 

1. This Agreement applies to conformity assessment procedures for products 

and/or processes and to other related cooperative activities as described in this 

Agreement. 

2. Sectoral Annexes may include: 

(a) a description of the relevant legislative, regulatory, and administrative 

provisions pertaining to the conformity assessment procedures and 

technical regulations; 

(b) a statement on the product scope and coverage; 

(c) a list of Designating Authorities; 

(d) a list of agreed conformity assessment bodies or authorities or a source 

from which to obtain a list of such bodies or authorities and a 

statement of the scope of the conformity assessment procedures for 

which each has been agreed; 

(e) the procedures and criteria for designating the conformity assessment 

bodies; 

(f) a description of the mutual recognition obligations; 

(g) a sectoral transition arrangement; 

(h) the identity of a sectoral contact point in each Party's territory; and 

(i) a statement regarding the establishment of a Joint Sectoral Committee. 

5 
I 

3. This Agreement shall not be construed to entail mutual acceptance of 

standards or technical regulations of the Parties and, unless otherwise specified in a 

Sectoral Annex, shall not entail the mutual recognition of the equivalence of 

standards or technical regulations. 

ARTICLE 5 

Designating Authorities 

Each Party shall ensure that the Designating Authorities specified in the Sectoral 

Annexes have the power and competence in their respective territories to carry out 

decisions under this Agreement to designate, monitor, suspend, remove suspension of, 

or withdraw conformity assessment bodies. 

ARTICLE6 

Designation and Listing Procedures 

The following procedures shall apply with regard to the designation of conformity 

assessment bodies and the inclusion of such bodies in the list of conformity 

assessment bodies in a Sectoral Annex: 

(a) The Designating Authority identified in a Sectoral Annex shall 

designate conformity assessment bodies in accordance with the 

procedures and criteria set forth in that Sectoral Annex; 

(b) A Party proposing to add a conformity assessment body to the list of 

such bodies in a Sectoral Annex shall forward its proposal of one or 

more designated conformity assessment bodies in writing to the other 

Party with a view to a decision by the Joint Committee; 

(c) Within 60 days following receipt of the proposal, the other Party shall 

indicate its position regarding either its confirmation or its opposition. 

Upon confirmation through a decision by the Joint Committee, the 

inclusion in the Sectoral Annex of the proposed conformity assessment 

body or bodies shall take effect; and 

(d) In the event that the other Party contests on the basis of documented 

evidence the technical competence or compliance of a proposed 

conformity assessment body, or indicates in writing that it requires an 

additional 3 0 days to more fully verify such evidence, such conformity 

6 
assessment body shall not be included on the list of conformity 

assessment bodies in the applicable Sectoral Annex. In this instance, 

the Joint Committee may decide that the body concerned be verified. 

After the completion of such verification, the proposal to list the 

conformity assessment body in the Sectoral Annex may be resubmitted 

to the other Party. 

ARTICLE 7 

Suspension of Listed Conformity Assessment Bodies 

The following procedures shall apply with regard to the suspension of a conformity 

assessment body listed in a Sectoral Annex: 

(a) A Party shall notify the other Party of its contestation of the technical 

competence or compliance of a conformity assessment body listed in a 

Sectoral Annex and its intent to suspend such conformity assessment 

body. Such contestation shall be exercised when justified in an 

objective and reasoned manner in writing to the other Party; 

(b) The conformity assessment body shall be given prompt notice by the 

other Party and an opportunity to present information in order to 

refute the contestation or to correct the deficiencies which form the 

basis of the contestation; 

(c) The Parties shall discuss any such contestation in the relevant Joint 

Sectoral Committee. If there is no Joint Sectoral Committee, the 

contesting Party shall refer the matter directly to the Joint Committee. 

If agreement to suspend is reached by the Joint Sectoral Committee or, 

if there is no Joint Sectoral Committee, by the Joint Committee, the 

conformity assessment body shall be suspended; 

(d) Where the Joint Sectoral Committee or Joint Committee decides that 

verification of technical competence or compliance is required, it shall 

normally be carried out in a timely manner by the Party in whose 

territory the body in question is located, but may be carried out jointly 

by the Parties in justified cases; 

(e) If the matter has not been resolved by the Joint Sectoral Committee 

within 10 days of the notice of contestation, the matter shall be referred 

to the Joint Committee for a decision. If there is no Joint Sectoral 

Committee, the matter shall be referred directly to the Joint 

7 
Committee. If no decision is reached by the Joint Committee within 

10 days of the referral to it, the conformity assessment body shall be 

suspended upon the request of the contesting Party; 

(f) Upon the suspension of a conformity assessment body listed in a 

Sectoral Annex, the contesting Party is no longer obligated to accept or 

recognize the results of conformity assessment procedures performed 

by that conformity assessment body subsequent to suspension. The 

contesting Party shall continue to accept the results of conformity 

assessment procedures performed by that conformity assessment body 

prior to suspension, unless a Regulatory Authority ofthat Party decides 

otherwise based on health, safety, or enviromnental considerations or 

failure to satisfy other requirements within the scope of the applicable 

Sectoral Annex; and 

(g) The suspension shall remain in effect until agreement has been reached 

by the Joint Committee with respect to the future status of that 

conformity assessment body. 

ARTICLE 8 

Withdrawal of Listed Conformity Assessment Bodies 

The following procedures shall apply with regard to the withdrawal from a Sectoral 

Annex of a conformity assessment body: 

(a) A Party proposing to withdraw a conformity assessment body listed in 

a Sectoral Annex shall forward its proposal in writing to the other 

Party; 

(b) Such conformity assessment body shall be promptly notified by the 

other Party and shall be provided a period of at least 30 days from 

receipt to provide information in order to refute or to correct the 

deficiencies which form the basis ofthe proposed withdrawal; 

(c) Within 60 days following receipt of the proposal, the other Party shall 

indicate its position regarding either its confirmation or its opposition. 

Upon confirmation through a decision by the Joint Committee, the 

withdrawal from the list in the Sectoral Annex of the conformity 

assessment body shall take effect; 

8 
(d) In the event that the other Party opposes the proposal to withdraw by 

supporting the technical competence and compliance of its conformity 

assessment body, the conformity assessment body shall not at that time 

be withdrawn from the list of conformity assessment bodies in the 

applicable Sectoral Annex. In this instance, the Joint Sectoral 

Committee or the Joint Committee may decide to carry out a joint 

verification of the body concerned. After the completion of such 

verification, the proposal for withdrawal of the conformity assessment 

body may be resubmitted to the other Party; and 

(e) Subsequent to the withdrawal of a conformity assessment body listed 

in a Sectoral Annex, the contesting Party shall continue to accept the 

results of conformity assessment procedures performed by that 

conformity assessment body prior to withdrawal, unless a Regulatory 

Authority of that Party decides otherwise based on health, safety, and 

environmental considerations or failure to satisfy other requirements 

within the scope of the applicable Sectoral Annex. 

ARTICLE9 

Monitoring of Conformity Assessment Bodies 

The following shall apply with regard to the monitoring of conformity assessment 

bodies listed in a Sectoral Annex: 

(a) Designating Authorities shall assure that their conformity assessment 

bodies listed in a Sectoral Annex are capable and remain capable of 

properly assessing conformity of products or processes, as applicable, 

and as covered in the applicable Sectoral Annex. In this regard, 

Designating Authorities shall maintain, or cause to maintain, ongoing 

surveillance over their conformity assessment bodies by means of 

regular audit or assessment; 

(b) The Parties undertake to compare methods used to verify that the 

conformity assessment bodies listed in the Sectoral Annexes comply 

with the relevant requirements of the Sectoral Annexes. Existing 

systems for the evaluation of conformity assessment bodies may be 

used as part of such comparison procedures; 

(c) A Designating Authority shall consult as necessary with its 

counterpart( s ), to ensure the maintenance of confidence in conformity 

assessment procedures. With the consent of each Party concerned, this 

9 
consultation may include joint participation in audits/inspections 

related to conformity assessment activities or other assessments of 

conformity assessment bodies listed in a Sectoral Annex; and 

(d) Designating Authorities shall consult, as necessary, with the relevant 

Regulatory Authorities of the other Party to ensure that all technical 

requirements are identified and are satisfactorily addressed. 

ARTICLE 10 

Conformity Assessment Bodies 

The United States and the United Kingdom recognize that the conformity assessment 

bodies listed in the Sectoral Annexes fulfill the conditions of eligibility to assess 

conformity in relation to their respective requirements as specified in the Sectoral 

Annexes, and they shall specify the scope of the conformity assessment procedures 

for which such bodies are listed. 

ARTICLE 11 

Exchange of Information 

1. The Parties shall exchange information concerning the implementation of the 

legislative, regulatory, and administrative provisions identified in the Sectoral 

Annexes. 

2. Each Party shall notify the other of legislative, regulatory, and administrative 

changes related to the subject matter of this Agreement at least 60 days before their 

entry into force. Where considerations of safety, health, or environmental protection 

require more urgent action, a Party shall notify the other Party as soon as practicable. 

3. Each Party shall promptly notify the other of any changes to its Designating 

Authorities and/or conformity assessment bodies. 

4. The Parties shall exchange information concerning the procedures used to 

ensure that the listed conformity assessment bodies under their responsibility comply 

with the legislative, regulatory, and administrative provisions outlined in the Sectoral 

Annexes. 

5. Regulatory Authorities identified in the Sectoral Annexes shall consult as 

necessary with their counterparts, to ensure the maintenance of confidence in 

10 
I conformity assessment procedures and to ensure that all technical requirements are 

identified and are satisfactorily addressed. I 

I ARTICLE 12 

Sectoral Contact Points 

II 

Each Party shall appoint and confirm in writing contact points to be responsible for 

activities under each Sectoral Annex. 

ARTICLE 13 

Joint Committee of the Parties 

1. The Parties hereby establish a Joint Committee consisting of representatives of 

each Party. The Joint Committee shall be responsible for the effective functioning of 

this Agreement. 

2. The Joint Committee may establish Joint Sectoral Committees comprised of 

appropriate Regulatory Authorities and others deemed necessary. 

3. Each Party shall each have one vote in the Joint Committee. The Joint 

Committee shall make its decisions by unanimous consent. The Joint Committee 

shall determine its own rules and procedures. 

4. The Joint Committee may consider any matter relating to the effective 

functioning of this Agreement. In particular it shall be responsible for: 

(a) · listing, suspension, withdrawal, and verification of conformity 

assessment bodies in accordance with this Agreement; 

(b) amending transitional arrangements in Sectoral Annexes; 

(c) resolving any questions relating to the application of this Agreement 

and its Sectoral Annexes not otherwise resolved in the respective Joint 

Sectoral Committees; 

(d) providing a forum for discussion of issues that may arise concerning 

the implementation of this Agreement; 

(e) considering ways to enhance the operation of this Agreement; 

11 
(f) coordinating the negotiation of additional Sectoral Annexes; and 

(g) considering whether to amend this Agreement or its Sectoral Annexes 

in accordance with Article 20(2). 

5. Following the entry into force of this Agreement, the Joint Committee shall 

consider decisions of the Joint Committee established under Article 14 of the 

Agreement on mutual recognition between the European Community and the United 

States ofAmerica in respect ofthe matters listed in paragraph 4. 

6. When a Party introduces new or additional conformity assessment procedures 

affecting a Sectoral Annex, the Parties shall discuss the matter in the JointCommittee 

with a view to bringing such new or additional procedures within the scope of this 

Agreement and the relevant Sectoral Annex. 

ARTICLE 14 

Preservation of Regulatory Authority 

1. Nothing in this Agreement shall be construed to limit the authority of a Party 

to determine, through its legislative, regulatory, and administrative measures, the 

level of protection it considers appropriate for safety; for protection of human, animal, 

or plant life or health; for the environment; for consumers; and otherwise with regard 

to risks within the scope ofthe applicable Sectoral Annex. 

2. Nothing in this Agreement shall be construed to limit the authority of a 

Regulatory Authority to take all appropriate and immediate measures whenever it 

ascertains that a product may: (a) compromise the health or safety of persons in its 

territory; (b) not meet the legislative, regulatory, or administrative provisions within 

the scope of the applicable Sectoral Annex; or ( c) otherwise fail to satisfy a 

requirement within the scope of the applicable Sectoral Annex. Such measures may 

include withdrawing the products from the market, prohibiting their placement on the 

market, restricting· their free movement, initiating a product recall, and preventing the 

recurrence of such problems, including through a prohibition on imports. If the 

Regulatory Authority talces such action, it shall inform its counterpart authority(ies) 

and the other Party within 15 days oftaking such action, providing its reasons. 

12 
ARTICLE 15 

Suspension of Recognition Obligations 

Either Party may suspend its obligations under a particular Sectoral Annex, in whole 

or in part, if: 

(a) it suffers a loss of market access for its products within the scope of 

the Sectoral Annex as a result of the failure of the other Party to fulfill 

its obligations under this Agreement; 

(b) the adoption of new or additional conformity assessment procedures, 

as referenced in Article 13(6), by the other Party results in a loss of 

market access for its products within the scope of the Sectoral Annex 

because conformity assessment bodies designated by it in order to meet 

such requirements have not been recognized by the other Party; or 

(c) the other Party fails to maintain legal and regulatory authorities 

capable of implementing the provisions of this Agreement. 

ARTICLE 16 

Confidentiality 

1. Each Party shall maintain, to the extent allowed under its laws, the 

confidentiality of information exchanged under this Agreement. 

2. In particular, no Party shall disclose to the public, nor permit a conformity 

assessment body to disclose to the public, information exchanged under this 

Agreement that constitutes trade secrets, confidential commercial or financial 

information, or information that relates to an ongoing investigation. 

3. A Party or a conformity assessment body may, upon exchanging information 

with the other Party or with a conformity assessment body of the other Party, 

designate the portions of the information that it considers to be exempt from 

disclosure. 

4. Each Party shall take all precautions reasonably necessary to protect 

information exchanged under this Agreement from unauthorized disclosure. 

13 
ARTICLE 17 

Fees 

Each Party shall endeavor to ensure that fees imposed for services under this 

Agreement shall be commensurate with the services provided. Each Party shall 

ensure that, for the sectors and conformity assessment procedures covered under this 

Agreement, it shall charge no fees with respect to conformity assessment services 

provided by the other Party. 

ARTICLE 18 

Agreements with Other Countries 

Except where there is written agreement between the Parties, obligations contained in 

mutual recognition agreements concluded by a Party with a party not a signatory to 

this Agreement (a third party) shall have no force and effect with regard to the other 

Party in terms of acceptance of the results of conformity assessment procedures in the 

third party. 

ARTICLE 19 

Territorial Application 

This Agreement shall apply, on the one hand, to the territory of the United States, and, 

on the other hand, to the territory of the United Kingdom and the territories of the Isle 

of Man and the Channel Islands. 

ARTICLE20 

Entry into Force, Amendment, Withdrawal, and Termination 

1. This Agreement, including its Sectoral Annexes on Telecommunications 

Equipment, Electromagnetic Compatibility, and Pharmaceutical Good Manufacturing 

Practices, shall enter into force on the date of the later notification in an exchange of 

written notifications between the Parties certifying that they have completed their 

respective internal requirements and procedures. In submitting a notification, the 

United Kingdom shall take account of its obligations arising in respect of any 

agreement between the European Union and the United Kingdom pursuant to Article 

50 of the Treaty on European Union. 

14 
2. The Parties may amend this Agreement, including the Sectoral Annexes, 

through written agreement. The Parties may add a Sectoral Annex to this Agreement 

by an exchange of letters. Any such Sectoral Annex shall enter into force on the first 

day of the second month following the date on which the Parties have exchanged 

notes confirming the completion of their respective procedures for the entry into force 

of such Sectoral Annex. The Joint Committee may also amend Sectoral Annexes in 

accordance with Article 13. 

3. Either Party may terminate this Agreement in its entirety or any individual 

Sectoral Annex thereof by giving the other Party six months' notice in writing. In the 

case of termination of one or more Sectoral Annexes, the Parties will seek to amend 

this Agreement, with a view to preserving the remaining Sectoral Annexes in 

accordance with the procedures in this Article. If the Parties cannot agree on an 

amendment to this Agreement or a Sectoral Annex, this Agreement or the relevant 

Sectoral Annex shall terminate at the end of six months from the date of notice. 

4. Following termination of this Agreement in its entirety or any individual 

Sectoral Annex thereof, a Party shall continue to accept the results of conformity 

assessment procedures performed by conformity assessment bodies under this 

Agreement prior to termination, unless a Regulatory Authority of that Party decides 

otherwise based on health, safety, and environmental considerations or failure to 

satisfy other requirements within the scope of the applicable Sectoral Annex. 

ARTICLE21 

Final Provisions 

1. The Sectoral Annexes referred to in Article 20(1 ), as well as any new Sectoral 

Annexes added pursuant to Article 20(2), shall form an integral part of this 

Agreement. 

2. For a given product or sector, the provisions contained in the relevant Sectoral 

Annexes shall apply in the first place, and the provisions of this Agreement in 

addition to those provisions. In the case of any inconsistency between the provisions 

of a Sectoral Annex and this text, the Sectoral Annex shall prevail, to the extent of 

that inconsistency. 

3. This Agreement shall not affect the rights and obligations of the Parties under 

any other international agreement. 

15 
IN WITNESS WHEREOF the undersigned, being duly authorized by their respective 

Governments, have signed this Agreement. 

DONE at Washington, D.C., in duplicate, this 14th day of February, 2019. 

~ · ~~iifaf/'• 1/ /LJ 

For the U~dStates of Ameri~a For the Unit ngdom of Great 

Britain and Northern Ireland 

16 
U.S.-UKMRA 

SECTORAL ANNEX 

FOR 

TELECOMMUNICATIONS EQUIPMENT 

PREAMBLE 

This Annex constitμtes a Sectoral Annex to the Agreement on Mutual Recognition 

Between the United States of America and the United Kingdom of Great Britain and 

Northern Ireland. 

17 
SECTION I 

LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE PROVISIONS 

United Kingdom United States 

Radio Equipment Regulations 2017 (SI Communication Act of 1934, as amended 

2017/1206); by the Telecommunication Act of 1996 

(Title 47 of the United States Code); 

For pure wired telecommunications The U.S. regulatory and administrative 

terminal equipment without a radio provisions in respect of 

component, see Electromagnetic telecommunications equipment, 

Compatibility Regulations (SI including 47 CFR Part 68, and FCC 

2016/1091). interpretation thereof; 

The U.S. regulatory and administrative 

provisions in respect of all radio 

transmitters subject to an equipment 

authorization requirement. A 

non-exclusive list of FCC regulations are 

contained in Section II; 

For electromagnetic compatibility 

aspects, see Electromagnetic 

Compatibility (EMC) Sectoral Annex to 

the Agreement. 

* * * * * 

18 
SECTION II 

SCOPE AND COVERAGE 

1. This Sectoral Annex shall apply to equipment, interfaces, and services subject 

to Section I. In general terms the provisions of this Sectoral Annex shall apply to the 

following types of telecommunications terminal equipment, satellite terminal 

equipment, radio transmitters, and information technology equipment: 

(a) equipment intended for connection to the public telecommunications 

network in order to send, process or receive information, whether the 

equipment is to be connected directly to the "termination" of the 

network or to inter-work with such a network, being connected directly 

or indirectly to the termination point. The system of connection may 

be wire, radio, optical or other electro-magnetic means; 

(b) equipment capable of being connected to a public telecommunications 

network even if it is not its intended purpose, including information 

technology equipment having a communication port; and 

(c) all radio transmitters subject to an equipment authorization procedure 

by each Party. 

2. The following is a non-exclusive list of the equipment, interfaces, and services 

included within the scope of this Sectoral Annex: 

United Kingdom United States 

U.S. access to the UK market: 

The following equipment categories are 

included: 

Pure wired telecommunications terminal 

equipment without a radio component 

covered by the EMC Regulation (SI 

2016/1091), including: 

ISDN Basic Rate Access 

ISDN Primary Rate Access 

ISDN Telephony 

X21/V.24N.35 Access 

UK access to the U.S. market: 

The following equipment categories are 

included: 

Telephone Terminal Equipment that are 

contained in the following: 

(1) 47 CFRPart68 and; 

(2) Documents published by the 

Administrative Council for 

Terminal Attachment (ACT A), 

established in the FCC CC 

19 
X25 Access 

PSTN Non-Voice 

PSTN Voice Band (Analog) 

ONP Leased Line Terminal types: 

-64 kbits/sec 

-2048 kbits/s unstructured 

-2048 kbits/s structured 

-34 Mbits/s access 

-140 Mbits/s access 

-2 wire analogue 

-4 wire analogue 

Radio equipment covered by the Radio 

Equipment Regulation (SI 2017 /1206) 

that is subject to equipment 

authorization, including: 

Short range devices, including low power 

devices such as cordless telephones/ 

microphones; 

Land mobile, including: 

- Private Mobile Radio (PMR/PAMR) 

- Mobile telecom 

- Paging systems 

Terrestrial fixed 

Satellite mobile 

Satellite fixed 

Broadcast 

Radio determination 

Docket 99-216. 

Radio transmitters subject to an 

equipment authorization requirement, 

including: 

Equipment Authorization Requirements 

(Part 2) 

Radio Frequency Devices (Part 15) 

Commercial Mobile Services (Part 20) 

Public Mobile Services (Part 22) 

Personal Communication Service (Part 

24) 

Satellite Communications (Part 25) 

Miscellaneous Wireless Communication 

Services (Part 27) 

Upper Microwave Flexible Use Service 

(Part 30) 

Broadcast (Part 73) 

Auxiliary Broadcast (Part 7 4) 

Cable Television Radio (Part 78) 

Maritime Services (Part 80) 

Aviation Services (Part 87) 

Private Land Mobile (Part 90) 

Personal Radio Services (Part 95) 

Citizens Broadband Radio Service (Part 

96) 

Amateur Radio (Part 97) 

Fixed Microwave Services (Part 101) 

Note: A list of acronyms and a glossary is contained in Appendix 1 to this Sectoral 

Annex. 

* * * * * 

20 
SECTION III 

CONFORMITY ASSESSMENT PROCEDURES 

FOR TELECOMMUNICATIONS EQUIPMENT 

1. Description of Mutual Recognition Obligations 

In accordance with the provisions of the Agreement, the results of the conformity 

assessment procedures produced by a Party's conformity assessment bodies listed in 

Section V shall be recognized by the Regulatory Authorities of the other Party without 

any further conformity assessment of the products, pursuant to Section I. 

2. Conformity Assessment Procedures 

Taking into account the legislative, regulatory, and administrative prov1s10ns as 

identified in Section I, each Party recognizes that the conformity assessment bodies of 

the other Party, listed in Section V, are authorized to perform the following 

procedures with regard to an importing Party's technical requirements for equipment 

identified in Section II: 

(a) testing and issuing oftest reports; 

(b) issuing certificates of conformity to the requirements of the laws and 

regulations applicable in the territories of the Parties for products 

covered under this Sectoral Annex; 

(c) performing procedures related to quality assurance approval pursuant 

to Radio Equipment Regulations 2017 (SI 2017/1206); and 

(d) performing procedures related to type examination pursuant to Radio 

Equipment Regulations 2017 (SI 2017/1206) and Electromagnetic 

Compatibility Regulations SI 2016/1091. 

* * * * * 

21 
SECTION IV 

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE 

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

United Kingdom United States 

Department for Business, Energy and 

Industrial Strategy (BEIS) 

National Institute of Standards and 

Technology (NIST) 

AUTHORITIES RESPONSIBLE FOR APPROVING THE CONFORMITY 

ASSESSMENT BODIES LISTED IN SECTION V 

United Kingdom United States 

Department for Business, Energy and 

Industrial Strategy (BEIS) 

Federal Communications Commission 

(FCC) 

* * * * * 

22 
SECTIONV 

CONFORMITY ASSESSMENT BODIES 

UK access to U.S. market 

Conformity assessment bodies located in 

the United Kingdom shall be designated 

by the UK Authorities identified in 

Section IV following the procedures set 

out in Section VI of this Annex. 

The United States confirms that the 

conformity assessment bodies located in 

the territory of the United Kingdom that 

were recognized by the United States the 

day preceding the entry into force ofthis 

Agreement shall continue to be 

recognized by the United States upon 

entry into force of this Agreement. 

After entry into force of this Agreement, 

the United States shall maintain an up-todate list online ofthe conformity 

assessment bodies located in the territory 

of the United Kingdom that have been 

recognized by U.S. Authorities. 

U.S. access to UK market 

Conformity assessment bodies located in 

the United States shall be designated by 

the U.S. Authorities identified in Section 

IV following the procedures set out in 

Section VI ofthis Annex. 

The United Kingdom confirms that the 

conformity assessment bodies located in 

the territory of the United States that 

were recognized by the United Kingdom 

the day preceding the entry into force of 

this Agreement shall continue to be 

recognized by the United Kingdom upon 

entry into force of this Agreement. 

After entry into force of this Agreement, 

the United Kingdom shall maintain an 

up-to-date list online of the conformity 

assessment bodies located in the territory 

ofthe United States that have been 

recognized by UK Authorities. 

* * * * * 

23 
SECTION VI 

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING, AND 

MONITORING CONFORMITY ASSESSMENT BODIES 

LISTED IN SECTION V 

UK access to U.S. market 

UK Authorities identified in Section IV 

shall designate conformity assessment 

bodies located in the United Kingdom in 

accordance with the legislative, 

regulatory, and administrative provisions 

of the United States identified in Section 

I that govern designation of conformity 

assessment bodies, based on compliance 

with the appropriate standards in the 

ISO/IEC 17000 series ( e.g., 17000, 

17011, 17020, 17025, and 17065). 

Procedures for designating, listing, 

suspending, withdrawing, and monitoring 

a conformity assessment body listed in 

Section V shall be undertaken pursuant to 

Articles 6, 7, 8, and 9 of the Agreement. 

U.S. access to UK market 

U.S. Authorities identified in Section IV 

shall designate conformity assessment 

bodies located in the United States in 

accordance with the legislative, 

regulatory, and administrative provisions 

of the United Kingdom identified in 

Section I that govern designation of 

conformity assessment bodies, based on 

compliance with the appropriate 

standards in the ISO/IEC 17000 series 

(e.g., 17000, 17011, 17020, 17025, and 

17065). 

Procedures for designating, listing, 

suspending, withdrawing, and monitoring 

a conformity assessment body listed in 

Section V shall be undertaken pursuant to 

Articles 6, 7, 8, and 9 of the Agreement. 

* * * * * 

24 
SECTION VII 

ADDITIONAL PROVISIONS 

1. SUB-CONTRACTING 

1.1 Any sub-contracting by conformity assessment bodies of one Party shall be in 

accordance with the sub-contracting requirements of the other Party. Notwithstanding 

the use of sub-contracting, the final results of conformity assessment remain the full 

responsibility of the listed conformity assessment body. 

1.2 The conformity assessment bodies shall record and retain details of their 

investigation of the competence and compliance of their subcontractors and maintain 

a register of all sub-contracting. These details will be made available to the other 

Party on request. 

2. POST-MARKET SURVEILLANCE, BORDER MEASURES, AND 

INTERNAL MOVEMENT 

2.1 For the purpose of post-market surveillance, the Parties may maintain any 

existing labeling and numbering requirements. The assignment of the numbers may 

take place in the territory of the exporting Party. The numbers will be allocated by the 

importing Party. Numbering and labeling systems shall not introduce additional 

requirements within the meaning of this Sectoral Annex. 

2.2 Nothing in this Sectoral Annex shall prevent the Parties from removing 

products from the market that do not in fact conform to the requirements for approval. 

2.3 Border inspections and checks of products which have been certified, labeled 

or marked as conforming with the importing Party's requirements specified in Section 

I shall be completed as expeditiously as possible. With regard to any inspections 

related to internal movement within their respective territories, these shall be 

completed in no less a favorable manner than for like-domestic goods. 

3. JOINT SECTORAL COMMITTEE 

3.1 A combined Joint Sectoral Committee for this Sectoral Annex and the EMC 

Sectoral Annex is hereby established (the JSC). The JSC shall meet as appropriate to 

discuss technical, conformity assessment, and technology issues relating to this 

Sectoral Annex and the EMC Sectoral Annex. The JSC shall determine its own rules 

of procedure. 

25 
3.2 The JSC consists of representatives of the United States and the United 

Kingdom for telecommunications and EMC. JSC representatives may each invite 

manufacturers and other entities as deemed necessary. The representatives for the 

United States shall have one vote in the JSC. The representatives of the United 

Kingdom shall have one vote in the JSC. Decisions of the JSC shall be made by 

unanimous consent. In the event of disagreement, either representatives of the United 

States or the United Kingdom may raise the matter in the Joint Committee. 

3.3 The JSC may address any matter related to the effective functioning of this 

Sectoral Annex, including: 

(a) providing a forum for discussion of issues and resolving problems that 

may arise concerning the implementation of this Sectoral Annex; 

(b) developing a mechanism for ensuring consistency of interpretations of 

legislation, regulations, standards, and conformity assessment 

procedures; 

(c) advising the Parties on matters relating to this Sectoral Annex; and 

(d) providing guidance. 

4. CONTACT POINT 

Each Party shall establish a contact point to provide answers to all reasonable 

inquiries from the other Party regarding procedures, regulations, and complaints under 

this Sectoral Annex. 

UK Contact Point 

Department for Business, Energy and 

Industrial Strategy (BEIS) 

I Victoria Street 

London 

SWlHOET 

United Kingdom 

U.S. Contact Point 

Federal Communications Commission 

(FCC) 

7435 Oakland Mills Road 

Columbia, MD 21046 

Tel: 301-362-3000 

Fax: 301-362-3290 

www.fcc.gov 

5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX 

In the event that there are changes to the legislative, regulatory, and administrative 

provisions referenced in Section I or the introduction of new legislative, regulatory, 

and administrative provisions affecting a Party's conformity assessment procedures 

26 
under the Agreement, such changes shall take effect for the purpose of this Sectoral 

Annex at the same time they take effect domestically within the territory of that Party. 

The Parties shall update this Sectoral Annex to reflect the changes. 

* * * * * 

27 
APPENDIX! 

LISTS OF ACRONYMS AND GLOSSARY 

CFR U.S. Code of Federal Regulations, Title 47 CFR 

FCC Federal Communications Commission 

IEC International Electrotechnical Commission 

ISDN Integrated Services Digital Network 

ISO International Organization for Standardization 

ITU International Telecommunications Union 

MRA Mutual Recognition Agreement 

NIST National Institute of Standards and Technology 

ONP Open Network Provision 

PSTN Public Switched Telephone Network 

X21 ITU-T Recommendation X21 

X25 ITU-T Recommendation X25 

* * * * * 

28 
U.S.-UKMRA 

SECTORAL ANNEX 

FOR 

ELECTROMAGNETIC COMPATIBILITY (EMC) 

PREAMBLE 

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition 

Between the United States of America and the United Kingdom of Great Britain and 

Northern Ireland. 

29 
' SECTION I 

LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE PROVISIONS 

United Kingdom 

Electromagnetic Compatibility 

Regulations 2016 (SI 2016/1091) 

For telecommunications equipment, 

terminal equipment, and radio 

transmitters, see also 

Telecommunications Equipment Sectoral 

Annex to the Agreement. 

United States 

Communications Act of 1934, as 

amended by the Telecommunication Act 

of 1996 (Title 4 7 of the United States 

Code); 

The U.S. regulatory and administrative 

provisions in respect of equipment 

subject to electromagnetic requirements 

including 47 CFR Parts 11, 15, and 18, 

and FCC interpretation thereof; 

For telecommunications equipment and 

radio transmitters, see also 

Telecommunications Equipment Sectoral 

Annex to the Agreement. 

Note: A list of acronyms and a glossary appears at Appendix 1 to the 

Telecommunications Equipment Sectoral Annex. 

* * * * * 

30 
SECTION II 

SCOPE AND COVERAGE 

United Kingdom United States 

U.S. access to the UK market: UK access to the U.S. market: 

Any product falling under the scope of Any products falling under the scope of 

Electromagnetic Compatibility 47 CFR Parts 11, 15, and 18. 

Regulations 2016 (SI 2016/1091 ), except 

for pure wired telecommunications 

terminal equipment covered by the 

sectoral annex for telecommunications 

equipment to this Agreement. 

* * * * * 

31 
SECTION III 

CONFORMITY ASSESSMENT PROCEDURES 

FOR EQUIPMENT IDENTIFIED IN SECTION II 

1. Description of Mutual Recognition Obligations 

In accordance with the provisions of the Agreement, the results of the conformity 

assessment procedures produced by a Party's conformity assessment bodies listed in 

Section V shall be recognized by the Regulatory Authorities of the other Party without 

any further conformity assessment of the products, pursuant to Section I. 

2. Conformity Assessment Procedures 

Taking into account the legislative, regulatory, and administrative proV1s10ns as 

identified in Section I, each Party recognizes that the conformity assessment bodies of 

the other Party, listed in Section V, are authorized to perform the following 

procedures with regard to an importing Party's technical requirements for equipment 

identified in Section II: 

(a) testing and issuing oftest reports; 

(b) issuing certificates of conformity to the requirements of the laws and 

regulations applicable in the territory of the importing Party for 

products covered under this Sectoral Annex; 

(c) performing procedures related to type examination pursuant to 

Electromagnetic Compatibility Regulations 2016 (SI 2016/1091). 

* * * * * 

32 
i 

SECTION IV 

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE 

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

United Kingdom United States 

Department for Business, Energy and National Institute of Standards and 

Industrial Strategy (BEIS) Teclmology (NIST) 

AUTHORITIES RESPONSIBLE FOR APPROVING THE CONFORMITY 

ASSESSMENT BODIES LISTED IN SECTION V 

United Kingdom United States 

Department for Business, Energy and Federal Communications Commission 

Industrial Strategy (BEIS) (FCC) 

* * * * * 

33 
SECTIONV 

CONFORMITY ASSESSMENT BODIES 

UK access to the U.S. market U.S. access to UK market 

Conformity assessment bodies located in 

the United Kingdom shall be designated 

by the UK Authorities identified in 

Section IV following the procedures set 

out in Section VI of this Annex. 

The United States confirms that the 

conformity assessment bodies located in 

the territory of the United Kingdom that 

were recognized by the United States the 

. day proceeding the entry into force of this 

Agreement shall continue to be 

recognized by the United States upon 

entry into force of this Agreement. 

After entry into force of this Agreement, 

the United States shall maintain an up-todate list online of the conformity 

assessment bodies located in the territory 

of the United Kingdom that have been 

recognized by U.S. Authorities. 

Conformity assessment bodies located in 

the United States shall be designated by 

the U.S. Authorities identified in Section 

IV following the procedures set out in 

Section VI of this Annex. 

The United Kingdom confirms that the 

conformity assessment bodies located in 

the territory of the United States that 

were recognized by the United Kingdom 

the day preceding the entry into force of 

this Agreement shall continue to be 

recognized by the United Kingdom upon 

entry into force of this Agreement. 

After entry into force of this Agreement, 

the United Kingdom shall maintain an 

up-to-date list online of the conformity 

assessment bodies located in the territory 

of the United States that have been 

recognized by UK Authorities. 

* * * * * 

34 
SRCTIONVI 

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING, AND 

MONITORING CONFORMITY ASSESSMENT BODIES 

LISTED IN SECTION V 

UK access to the U.S. market U.S. access to UK market 

UK Authorities identified in Section IV U.S. Authorities identified in Section IV 

shall designate conformity assessment shall designate conformity assessment 

bodes located in the United Kingdom in bodies located in the United States in 

accordance with the legislative, accordance with the legislative, 

regulatory, and administrative provisions regulatory, and administrative provisions 

of the United States identified in Section of the United Kingdom identified in 

I that govern designation of conformity Section I that govern designation of 

assessment bodies, based upon conformity assessment bodies, based on 

compliance with the appropriate compliance with the appropriate 

standards in the ISO/IEC 17000 series standards in the ISO/IEC 17000 series 

(e.g., 17000, 17011, 17020, 17025. and (e.g., 17000, 17011, 17020, 17025, and 

17065). 17065). 

Procedures for designating, listing, Procedures for designating, listing, 

suspending, withdrawing, and monitoring suspending, withdrawing, and monitoring 

a conformity assessment body listed in a conformity assessment body listed in 

Section V shall be undertaken pursuant to Section V shall be undertaken pursuant to 

Articles 6, 7, 8, and 9 of the Agreement. Articles 6, 7, 8, and 9 of the Agreement. 

* * * * * 

35 

·"' 
SECTION VII 

ADDITIONAL PROVISIONS 

1. SUB-CONTRACTING 

1.1 Any sub-contracting by conformity assessment bodies of one Party shall be in 

accordance with the sub-contracting requirements of the other Party. Notwithstanding 

the use of sub-contracting, the final results of conformity assessment remain the full 

responsibility of the listed conformity assessment body. 

1.2 The conformity assessment bodies shall record and retain details of their 

investigations of the competence and compliance of their subcontractors and maintain 

a register of all sub-contracting. These details will be made available to the other 

Party on request. 

2. POST-MARKET SURVEILLANCE, BORDER MEASURES AND 

INTERNAL MOVEMENT 

2.1 For the purpose of post-market surveillance, the Parties may maintain any 

existing labeling and numbering requirements. The assignment of the numbers may 

take place in the territory of the exporting Party. The numbers will be allocated by the 

importing Party. Numbering and labeling systems shall not introduce additional 

requirements within the meaning of this Sectoral Annex. 

2.2 Nothing in this Sectoral Annex shall prevent the Parties from removing 

products from the market that do not in fact conform to the requirements for approval. 

2.3 Border inspections and checks of products which have been certified, labeled 

or marked as conforming with the importing Party's requirements specified in Section 

I shall be completed as expeditiously as possible. With regard to any inspections 

related to internal movement within their respective territories, these shall be 

completed in no less a favorable manner than for like-domestic goods. 

3. JOINT SECTORAL COMMITTEE 

3.1 A combined Joint Sectoral Committee for this Sectoral Annex and the 

Telecommunications Equipment Sectoral Annex is hereby established (the JSC). The 

JSC shall meet as appropriate to discuss technical, conformity assessment, and 

technology issues relating to this Sectoral Annex and the Telecommunications 

Equipment Sectoral Annex. The JSC shall determine its own rules of procedure. 

36 
3.2 The JSC consists of representatives of the United States and the United 

Kingdom for telecommunications and EMC. JSC representatives may each invite 

manufacturers and other entities as deemed necessary. The representatives for the 

United States shall have one vote in the JSC. The representatives of the United 

Kingdom shall have one vote in the JSC. Decisions of the JSC shall be made by 

unanimous consent. In the event of disagreement, either representatives of the United 

States or the United Kingdom may raise the matter in the Joint Committee. 

3.3 The JSC may address any matter related to the effective functioning of this 

Sectoral Annex, including: 

(a) providing a forum for discussion of issues and resolving problems that 

may arise concerning the implementation ofthis Sectoral Annex; 

(b) developing a mechanism for ensuring consistency of interpretations of 

legislation, regulations, standards, and conformity assessment 

procedures; 

(c) advising the Parties on matters relating to this Sectoral Annex; and 

(d) providing guidance. 

4. CONTACT POINTS 

Each Party shall establish a contact point to provide answers to all reasonable 

inquiries from the other Party regarding procedures, regulations, and complaints under 

this Sectoral Annex. 

UK Contact Point U.S. Contact Point 

Department for Business, Energy and 

Industrial Strategy (BEIS) 

1 Victoria Street 

London 

SWIHOET 

United Kingdom 

Federal Communications Commission 

(FCC) 

7435 Oakland Mills Road 

Columbia, MD 21046 

Tel: 301-362-3000 

Fax: 301-362-3290 

www.fcc.gov 

37 
5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX 

In the event that there are changes to the legislative, regulatory, and administrative 

provisions referenced in Section I or the introduction of new legislative, regulatory, 

and administrative provisions affecting a Party's conformity assessment procedures 

under the Agreement, such changes sha11 take effect for the purpose of this Sectoral 

Annex at the same time they take effect domestica1ly within the territory of that Party. 

The Parties shall update this Sectoral Annex to reflect the changes. 

****** 

38 
U.S.-UKMRA 

SECTORAL ANNEX 

FOR 

PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs) 

PREAMBLE 

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition 

Between the United States of America and the United Kingdom of Great Britain and 

Northern Ireland. 

39 
ARTICLE 1 

Definitions 

For purposes of this Annex: 

1. "Assessment pursuant to this Sectoral Annex" means: 

for the United Kingdom, an equivalence assessment; and 

for the United States, a capability assessment. 

An assessment pursuant to this Sectoral Annex includes a reassessment. 

2. "Recognized authority" means: 

for the United Kingdom, an equivalent authority; and 

for the United States, a capable authority. 

3. "Capable authority" means an authority that the U.S. Food and Drug 

Administration (FDA) has determined is capable according to the criteria and 

procedures specified in Appendix 4 and referred to in the U.S. laws, regulations, and 

administrative provisions listed in Appendix 1. For greater certainty, a finding that a 

regulatory authority is "capable" does not require that the authority maintain 

procedures for conducting inspections and overseeing manufacturing facilities that 

are identical to FDA's procedures. 

4. "Equivalent authority" means an authority in respect of which the United 

Kingdom has made a positive equivalence determination according to the criteria and 

procedures specified in Appendix 4 and as referred to in the UK laws, regulations, 

and administrative provisions listed in Appendix 1. 

5. "Equivalence" means that the regulatory system under which an authority 

operates is sufficiently comparable to assure that the process of inspection and the 

ensuing official GMPs documents will provide adequate information to determine 

whether respective statutory and regulatory requirements of the authorities have been 

fulfilled. For greater certainty, "equivalence" does not require that the respective 

regulatory systems have identical procedures. 

6. "Enforcement" means an action taken by an authority to protect the public 

from products of suspect quality, safety, and efficacy or to assure that products are 

40 
manufactured in compliance with appropriate laws, regulations, standards, and 

commitments made as part of the approval to market a product. 

7. "Good Manufacturing Practices" (GMPs) means systems that assure proper 

design, monitoring, and control of manufacturing processes and facilities, the 

adherence to which assures the identity, strength, quality, • and purity of 

pharmaceuticals. GMPs include strong quality management systems, obtaining 

appropriate quality raw materials (including starting materials) and packaging 

materials, establishing robust operating procedures, detecting and investigating 

product quality deviations, and maintaining reliable testing laboratories. 

8. "Inspection" means an on-site evaluation of a manufacturing facility to 

determine whether such manufacturing facility is operating in compliance with 

GMPs and/or commitments made as part of the approval to market a product. 

9. "Inspection Report" means a report written by an investigator or inspector of 

an authority listed in Appendix 2 concerning an inspection of a manufacturing 

facility that the investigator or inspector conducted that describes the purpose and 

scope of an inspection and includes written observations and findings bearing on the 

manufacturing facilities conformance to applicable GMPs requirements set out in 

the laws, regulations, and administrative procedures listed in Appendix 1 and any 

commitments made as part of the approval to market a product. 

10. "Official GMPs document" means a document issued by an authority listed 

in Appendix 2 following an inspection of a manufacturing facility. Examples of 

official GMPs documents include inspection reports, certificates issued by an 

authority attesting the compliance of a manufacturing facility with GMPs, GMPs 

non-compliance statement issued by a UK authority, and notices of observation, 

untitled letters, warning letters, and import alerts issued by the FDA. 

11. "Pharmaceuticals" includes drugs and medicinal products as defined in the 

laws and regulations listed in Appendix 1. 

12. "Post-approval inspections" means application specific inspections following 

a recent authorization carried out in the territory of a Party. 

13. "GMP surveillance inspections" means inspections of pharmaceuticals 

manufacturing facilities conducted in the territory of a Party during the marketing of 

products. 

41 
14. "Pre-approval inspections" means pharmaceutical inspections of 

manufacturing facilities carried out in the territory of a Party as part of the review of 

an application before marketing approval is granted. 

15. "Regulatory System" means the body of legal requirements for GMPs, 

inspections, and enforcements that ensure public health protection and legal 

authority to assure adherence to these requirements. 

ARTICLE2 

Purpose 

This Sectoral Annex facilitates the exchange of official GMPs documents between 

the Parties and reliance on the factual findings in such documents. This Sectoral 

Annex seeks to facilitate trade and benefit public health by allowing each Party to 

leverage and to reallocate its inspection resources, including by avoiding duplication 

of inspections, so as to improve oversight of manufacturing facilities and better 

address quality risk and prevent adverse health consequences. 

ARTICLE3 

Scope 

1. The prov1s10ns of this Sectoral Annex apply to GMP surveillance 

inspections and, to the extent provided for in Article 9 ofthis Sectoral Annex, pre- and 

post-approval inspections, as well as, to the extent provided for in Article 6.3 of this 

Sectoral Annex, to pharmaceutical inspections of manufacturing facilities carried 

out outside the territory of either Party. 

2. Appendix 1 names the laws, regulations, and administrative prov1s10ns 

governing these inspections and the GMPs requirements. 

3. Appendix 2 lists all the authorities responsible for the oversight of facilities 

that manufacture products within the product coverage ofthis Sectoral Annex. 

4. Articles 5, 6, 7, 8, 9, 10, and 11 of the Agreement do not apply to this 

Sectoral Annex. 

42 
ARTICLE4 

Product Coverage 

1. The prov1s10ns of this Sectoral Annex apply to marketed finished 

pharmaceuticals for human or animal use, intermediates (for the United Kingdom 

as defined in UK legislation) and in-process materials (for the United States as 

defined under U.S. law), certain marketed biological products for human use, and 

active pharmaceutical ingredients, only to the extent they are regulated by the 

authorities of both Parties as listed in Appendix 2 and subject to Article 17 of this 

Sectoral Annex. 

2. Human blood, human plasma, human tissues and organs, and veterinary 

immunologicals are excluded from the scope ofthis Sectoral Annex. 

3. Appendix 3 contains the list of products covered by this Sectoral Annex. 

ARTICLES 

Recoguitiou of Authorities 

1. For purposes of this Sectoral Annex, the United States confirms that it 

recognizes the Medicines and Healthcare product Regulatory Agency (MHRA) as a 

capable authority according to the criteria and procedure specified in Appendix 4. 

2. For purposes of this Sectoral Annex, the United Kingdom confirms that it 

recognizes the FDA as an equivalent authority according to the criteria and procedure 

specified in Appendix 4. 

ARTICLE6 

Recognition of Inspections 

1. A Party shall recognize pharmaceutical inspections and accept official 

GMPs documents issued by a recognized authority of the other Party for 

manufacturing facilities located in the territory of the issuing authority, except as 

provided in paragraph 2. 

2. A Party may in specific circumstances opt not to accept an official GMPs 

document issued by a recognized authority of the other Party for manufacturing 

43 
facilities located in the territory of the issuing authority. Examples of such 

circumstances include the indication of material inconsistencies or inadequacies in 

an inspection report, quality defects identified in the post-market surveillance, or 

other specific evidence of serious concern in relation to product quality or consumer 

safety. A Party opting not to accept an official GMPs document issued by a 

recognized authority of the other Party shall notify the other Party and the relevant 

authority of the reasons for not accepting the document and may request clarification 

from that authority. The authority shall endeavour to respond to the request for · 

clarification in a timely manner and shall normally provide the clarification based 

on input from one or more members ofthe inspection team. 

3. A Party may accept official GMPs documents issued by a recognized 

authority of the other Party for manufacturing facilities located outside the territory 

of the issuing authority. 

4. Each Party may determine the terms and conditions under which it accepts 

official GMPs documents issued under paragraph 3. 

5. For purposes of this Sectoral Annex, to accept an official GMPs document 

means to rely on the factual findings in such document. 

ARTICLE 7 

Batch Testing 

In the United Kingdom, as provided in The Veterinary Medicines Regulations 2013 

(SI 2013/2033) and The Human Medicines Regulations 2012 (SI 2012/1916), the 

qualified person will be relieved of responsibility for carrying out the controls laid 

down in The Veterinary Medicines Regulations 2013 (SI 2013/2033) and The Human 

Medicines Regulations 2012 (SI 2012/1916) provided that these controls have been 

carried out in the United States, the product was manufactured in the United 

States, and that each batch/lot is accompanied by a batch certificate (in alignment 

with the WHO Certification Scheme on the quality of pharmaceutical products) 

issued by the manufacturer certifying that the product complies with requirements 

of the marketing authorization and signed by the person responsible for releasing 

the batch/lot. 

44 
ARTICLE 8 

Transmission of Official GMPs Documents 

If an importing Party requests a recognized authority of the other Party for an official 

GMP surveillance inspection document, the recognized authority shall transmit the 

document to the importing Party within 30 calendar days of the date of the request. If, 

based on that document, the importing Party determines that a new inspection of the 

manufacturing facility is needed, the importing Party shall notify the relevant 

recognized authority of the other Party and request, in accordance with Article 9 of 

this Sectoral Annex, the recognized authority of the other Party to conduct a new 

inspection. 

ARTICLE 9 

Requests for Pre-approval, Post-approval, and GMP Surveillance Inspections 

I. A Party or a recognized authority of a Party may request in writing that a 

recognized authority of the other Party conduct a pre-approval, post-approval, or 

GMP surveillance inspection of a manufacturing facility. The request shall include 

the reason for the request and identify the precise issues to be addressed in the 

inspection and the requested timeline for completing the inspection and transmitting 

the official GMPs documents. 

2. In the United Kingdom, requests shall be sent directly to the relevant 

recognized authority. 

3. Within 15 calendar days of receipt of the request, the recognized authority 

shall acknowledge receipt and confirm whether it will conduct the inspection in 

accordance with the requested timelines. Where the authority receiving the request 

is of the opinion that official GMPs documents relevant to the request are already 

available or are pending, it should inform the requesting authority accordingly and 

share these documents upon request. 

4. For greater certainty, if the recognized authority indicates that it will not 

conduct the inspection, the requesting authority has the right to conduct its own 

inspection of the manufacturing facility and the requested authority has the right to 

join the inspection. 

45 

'~ 
ARTICLE 10 

Maintenance 

Each Party shall maintain ongoing activities to monitor whether recognized 

authorities in its territory are maintaining the criteria for recognition. For the 

purpose of such monitoring activities, each Party shall rely on established 

programmes that include regular audits or assessments of authorities based on the 

criteria specified in Appendix 4. The frequency and nature of such activities shall 

be consistent with international best practices. A Party may invite the other Party 

to participate in these monitoring activities at the other Party's expense. Each Party 

shall notify the other Party of any significant changes to its monitoring 

progranunes. 

ARTICLE 11 

Suspension of a Recognized Authority 

1. Each Party has the right to suspend recognition of a recognized authority of 

the other Party. This right shall be exercised in an objective and reasoned manner 

and communicated in writing to the other Party and the recognized authority. 

2. A Party suspending recognition of a recognized authority of the other Party 

shall, upon request of the other Party or the authority whose recognition was 

suspended, promptly discuss in the Joint Sectoral Committee set up in accordance 

with Article 12 of this Sectoral Annex, the suspension, the reason for the 

suspension, and corrective actions that would need to be taken for the suspension to 

be lifted. Efforts shall be made by the Joint Sectoral Committee to discuss within 

three months of the suspension the appropriate timeframe and exact steps to be taken 

to lift the suspension or reassess the relevant authority according to the criteria 

specified in Appendix 4. 

3. Upon the suspension of an authority listed as a recognized authority, a Party 

is no longer obligated to accept official GMPs documents of the suspended 

authority. A Party shall continue to accept official GMPs documents of that 

authority prior to suspension, unless the Party decides otherwise based on health or 

safety considerations. The suspension shall remain in effect until the Parties decide 

to lift the suspension or until a positive determination of recognition has been made 

pursuant to a reassessment in accordance with the criteria specified in Appendix 4. 

46 
4. A Party suspending recognition of a recognized authority of the other Party 

shall promptly notify the other Party of the reasons for the suspension and provide 

sufficient detail to allow the authority of the other Party to understand corrective 

measures that must be taken to lift the suspension or to attain a positive determination 

of recognition pursuant to a reassessment. 

ARTICLE 12 

Role and Composition of the Joint Sectoral Committee 

1. A Joint Sectoral Committee is set up_ to monitor the activities performed 

under this Sectoral Annex. 

2. The Joint Sectoral Committee shall be co-chaired by a representative from 

the FDA for the United States and a representative of the United Kingdom, who 

each shall have one vote in the Joint Sectoral Committee. The Joint Sectoral 

Committee shall make its decision by unanimous consent. The Joint Sectoral 

Committee shall determine its own rules and procedures. 

3. The Joint Sectoral Committee's functions include in particular: 

(a) developing and keeping up to date the list of recognized authorities, 

including any limitation in terms of inspection type or products and 

the list of authorities in Appendix 2, and communicating the lists to all 

authorities listed in Appendix 2 and the Joint Committee; 

(b) providing a forum to discuss issues relating to this Sectoral Annex; 

(c) in accordance with Article 17 and Appendix 3 of this Sectoral Annex, 

considering the status, and talcing decisions on the inclusion, of the 

products referred to in Article 17 of this Sectoral Annex; and 

(d) adopting, where necessary, appropriate complementary technical and 

administrative arrangements for the effective implementation of this 

Sectoral Annex. 

4. The Joint Sectoral Committee shall meet at the request of either Party with 

respect to issues relating to disagreements as regards to determinations of 

recognition or suspension and otherwise at such times as the Parties may agree. 

The Joint Sectoral Committee may meet in person or by other means. 

47 
ARTICLE 13 

Regulatory Cooperation 

The Parties shall inform and consult one another, as permitted by law, on 

proposals to introduce new controls or to change existing technical regulations or 

significant changes to pharmaceutical inspection procedures and to provide the 

opportunity to comment on such proposals. 

ARTICLE 14 

Exchange of Information 

The Parties shall establish appropriate arrangements, including access to relevant 

databases, for the exchange of official GMPs documents and other appropriate 

information related to the inspection of a manufacturing facility and the exchange 

of information concerning any confirmed problem reports, corrective actions, 

recalls, rejected import consignments, and other regulatory and enforcement 

problems for products subject to this Sectoral Annex. 

ARTICLE 15 

Alert System 

Each Party shall maintain an Alert System that permits authorities of the other 

Party when relevant to be made aware proactively and with the appropriate speed 

in case of quality defect, recalls, counterfeit or falsified products, or potential 

serious shortages and other problems concerning quality or non-compliance with 

GMPs, which could necessitate additional controls or suspension of the 

distribution of the affected products. 

ARTICLE 16 

Safeguard Clause 

1. Each Party recognizes that the importing Party has a right to fulfil its legal 

responsibilities by taking actions necessary to ensure the protection of human and 

animal health at the level of protection it deems appropriate. An authority of a 

48 
Party has the right to conduct its own inspection of a manufacturing facility in the 

territory of the other Party. 

2. An authority of a Party conducting its own inspection of a manufacturing 

facility in the territory ofthe other Party should be an exception from the normal 

practice of a Party as of the date on which this Sectoral Annex enters into force. 

3. An authority of a Party, prior to conducting an inspection under paragraph 1, 

shall notify the other Party in writing, and the authority ofthe other Party has the right 

to join the inspection conducted by the Party. 

ARTICLE 17 

Transitory Provisions 

1. No later than four months following the entry into force of this Agreement, 

the Joint Sectoral Committee shall consider whether to include veterinary 

products with the product coverage of this Sectoral Annex. 

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 Sectoral Annex. Without prejudice to this 

consideration, as of the effective date of this Sectoral 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 

suchjoint inspections. 

3. No later than four months following the entry into force of this Agreement, 

the Joint Sectoral Committee shall review experience gained in order to decide 

whether the provisions on pre- and post-approval inspections provided in Article 9 of 

this Sectoral Annex shall be reviewed. Each party may decide to postpone this review 

until nine months following the entry into force of this Agreement. 

4. Products referred to in paragraphs 1 and 2 shall be included within the 

product coverage of this Sectoral Annex only once the Joint Sectoral Committee so 

decides pursuant to paragraphs 1 and 2. 

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APPENDIX 1 

List of Applicable Laws. Regulations, and Administrative Provisions 

For the United States: 

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq. Of particular 

relevance: 21 U.S.C. 351(a)(2)(B) (drug adulterated if not manufactured in 

conformance with current good manufacturing practice); 21 U.S.C. 355(d)(3); 21 

U.S.C. 355(j)(4)(A) (approval of human drug contingent on adequacy of methods, 

facilities, and controls for manufacturing, processing, and packing to preserve the 

identity, strength, quality, and purity of drug); 21 U.S.C. 360b(c)(2)(A)(i) and 

360b(d)(l)(C) (approval of animal drug contingent on adequacy of methods, 

facilities, and controls for manufacturing, processing, and packing to preserve the 

identity, strength, quality, and purity of drug); 21 U.S.C. 374 (inspection authority); 

21 U.S.C. 384(e) (recognition of foreign government inspections) 

Public Health Service Act Section 351, 42 U.S.C. 262. Of particular relevance: 42 

U.S.C. 262(a)(2)(C)(i)(II) (licensing of biologic contingent on demonstration that 

the facility in which it is manufactured, processed, packed, or held meets standards 

designed to assure that the product continues to be safe, pure, and potent); 42 U.S.C. 

262(j) (Federal Food, Drug, and Cosmetic Act applies to biologic products) 

21 CPR Part 210 (Current Good Manufacturing Practice in Manufacturing, 

Processing, Packing or Holding Drugs; General) 

21 CPR Part 211 (Current Good .Manufacturing Practice for Finished 

Pharmaceuticals) 

21 CPR Part 600, Subpart B (Establishment Standards) and Subpart C 

(Establishment Inspection) 

For the United Kingdom: 

The Human Medicines Regulations 2012 (SI 2012/1916) 

The Veterinary Medicines Regulations 2013 (SI 2013/2033) 

The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) 

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Current version of the Guide to good manufacturing practices found at 

https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distributionpractice governing medicinal products in the United Kingdom and compilation of 

the community procedures on inspections and exchange of information. 

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APPENDIX2 

List ofAuthorities 

United States: 

Food and Drug Administration 

United Kingdom: 

Medicines and Healthcare products Regulatory Agency 

Veterinary Medicines Directorate 

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APPENDIX3 

List ofProducts Covered by the Sectoral Annex 

Recognizing that precise definition of medicinal products and drugs are to be found in 

the laws, regulations, and administrative provisions referred to in Appendix 1, an 

indicative list ofproducts covered by the Sectoral Annex is given below. This applies to 

processing, packaging, testing, and sterilizing facilities, including contract facilities 

performing these functions. 

1. Marketed finished pharmaceuticals for human use in various pharmaceutical 

dosage forms such as tablets, capsules, ointments, and injectables, including: 

(a) Medical gases; 

(b) Radiopharmaceuticals or radioactive biological products; 

(c) Herbal (botanical)products*; and 

(d) Homeopathic products. 

2. Marketed biological products: 

(a) Vaccines for human use**; 

(b) Plasma derived pharmaceuticals**; 

(c) Therapeutic biotechnology-derived biological products; and 

(d) Allergenic products. 

3. In process materials (for the United States as defined under U.S. law) and 

intermediates (for the United Kingdom as defined in UK legislation); 

4. Active pharmaceutical ingredients or bulk drug substance; 

5. Investigational products ( clinical trial material)***; and 

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r 

6. Veterinary products** : 

(a) veterinary pharmaceuticals, including prescription and nonprescription drugs, with the exclusion of veterinary immunologicals; 

and 

(b) pre-mixes for the preparation of veterinary medicated feeds (UK), 

Type A medicated articles for the preparation of veterinary medicated 

feeds (U.S.). 

* These are included to the extent that they are regulated as drugs by the FDA and 

medicinal products by the United Kingdom. 

* * These products are only included within the product coverage of this Sectoral 

Annex to the extent the Joint Sectoral Committee decides to include them pursuant 

to Article 17 of this Sectoral Annex. 

*** The FDA does not routinely conduct GMP surveillance inspections for 

investigational medicinal products. Inspection information on these products will 

be provided to the extent that they are available and resources allow. These 

products are only included within the product coverage of this Sectoral Annex to 

the extent the Joint Sectoral Committee decides to include them. 

54 
APPENDIX4 

Criteria and Procedure for Assessments Under this Sectoral Annex 

I. Criteria for Assessments under this Sectoral Annex 

Each Party will apply the following criteria to determine whether to recognize an 

authority listed in Appendix 2: 

(i) The authority has the legal and regulatory authority to conduct 

inspections against a standard for GMPs ( as defined in Article 1 of 

this Sectoral Annex). 

(ii) The authority manages conflict of interest in an ethical manner. 

(iii) The authority has the ability to evaluate risks and mitigate them. 

(iv) The authority maintains appropriate oversight of manufacturing 

facilities within its jurisdiction. 

(v) The authority has and uses sufficient resources. 

(vi) The authority employs trained and qualified inspectors with the skills 

and knowledge identify manufacturing practices that may lead to 

patient harm. 

(vii) The authority has the tools necessary to take action to protect the 

public from harm due to poor quality drugs or medicinal products. 

IL Procedures for Assessment under this Sectoral Annex 

A. Assessment of UK authorities by FDA 

1. To receive a capability assessment for an authority listed in Appendix 

2, the United Kingdom shall submit capability assessment packages 

containing the following materials before the FDA will initiate an 

assessment: 

(i) a finalized PIC/S audit report of an audit, where the FDA has been 

given three months advance notice to be an ·observer, that includes 

the full report of the observed inspection, any associated corrective 

measures, and all documents cited by the auditors in the report for 

55 
1 the indicators as identified by FDA in the audit checklist as essential 

for the assessment and for any indicators that required the authority 

to propose a corrective and preventative action; 

(ii) a completed conflicts of interest questionnaire established by the 

FDA signed by a principal of the authority; 

(iii) a total of four inspection reports including the report from the 

inspections observed during the PIC/S audit; 

(iv) standard operating procedures or a description on how the authority 

finalizes inspection reports; 

(v) standard operating procedures related to training and inspector 

qualification, including training files for all inspectors who conducted 

the inspections in the reports provided to the FDA (pursuant to 

subparagraph (iii)); and 

(vi) its most recent inventory of manufacturing facilities within its 

territory and under the authority's jurisdiction, including type of 

manufacturing facility of products falling within the product 

coverage of this Sectoral Annex, and upon request, completion of a 

table provided by the FDA detailing types of manufacturing 

facilities. 

2. During a capability assessment, the FDA may require additional 

information or further clarification from a UK authority. 

3. The FDA may waive the requirement to submit certain information 

listed under IIA. I and may request alternative information from a UK 

authority. The decision to waive any assessment materials will be made by 

the FDA on a case by case basis. 

B. Assessment ofFDA by the United Kingdom 

The United Kingdom will carry out its assessment of FDA based on: 

(i) The performance of an audit in the framework of the Pharmaceutical 

Inspection Convention/Scheme (PIC/S) and audits performed in the 

context of the Human Medicines Regulation 2012, in particular 

regulation 450 ofthose Regulations. 

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(ii) An assessment of the equivalence of legislative and regulatory 

GMPs requirements. 

C. Reassessment of an authority 

In the event an assessing Party issues a suspension or negative determination of an 

authority of the other Party, it may reassess the authority. The scope of the 

reassessment shall relate to the reasons for the negative determination or 

suspens10n. 

III. Maintaining Recognition 

To maintain recognition, it is required that the authority continue to meet the criteria 

set out in paragraph I.A and remain subject to the monitoring activities described in 

Article 10 of this Sectoral Annex, which for a UK authority the FDA requires 

monitoring through an audit program that includes an audit (that the FDA has the 

option to observe) of each recognized UK authority every five to six years. In case an 

authority has not been subject to an audit for a period of six years, the other Party 

shall have the right to audit such authority. 

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