AGREEMENT ON MUTUAL RECOGNITION BETWEEN THE SWISS 
CONFEDERATION AND THE UNITED STATES OF AMERICA RELATING TO 
PHARMACEUTICAL GOOD MANUFACTURING PRACTICE  
 
 The Swiss Confederation (“Switzerland”)  and the United States of America (“the United 
States”) (individually a “Party” and collectively the “Parties”),  
 
CONSIDERING the traditional links of friendship that exist between Switzerland and the United States ; 
 RECOGNIZING the U.S. Food and Drug Admi nistration’s (FDA) mission to protec t 
the public health by ensuring the safety, efficacy, and security of human drugs and 
biological products and veterinary drugs ; 
 RECOGNIZING the Swiss Agency for Therapeutic Products ’ (Swissmedic)  mission to 
protec t the public health by ensuring the safety, efficacy, and security of therapeutic 
products;  
 DESIRING to facilitate bilateral trade between the Parties;  RECOGNIZING the importance of continued and enhanced collaboration between 
Swissmedic and FDA  to advanc e protection of public health;  
 RECOGNIZING that mutual recognition of pharmaceutical good manufacturing practice inspections can be an important means of enhancing public health outcomes in both Parties;  
 RECOGNIZING that an agreement providing for mutual recognition is of particular interest to small-  and medium -sized businesses , and their workers, of  both Parties;  
 RECOGNIZING that any such mutual recognition depends on the confidence in the continued reliability of inspection procedures and practi ces of each Party;  and 
 RECOGNIZING the importance of maintaining the high levels of health, safety, environmental, and consumer protection in each Party,  
HAVE AGREED as follows:  
  
Section A:  Pharmaceutical Inspections  
  Article 1:  Definitions  
 
For purposes of this Agreement:  
 Assessment
1 means:  
 
(a) for Switzerland,  an equivalence assessment done by Swissmedic ; and 
 
(b) for the  United States, a capability  assessment done by FDA ; 
  
 
1 For greater certainty, an “ assessment ” for purposes of  this Agreement includes any reassessment.      Authority means:  
 
(a) For Swissmedic, an equivalent authority; and  
 
(b) For FDA, a capable authority ; 
 Capable Authority means an A uthority that FDA has determined is capable according to the 
criteria and procedures specified in Annex 3 and referred to in the U.S. laws and regulations 
listed in Annex 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 the FDA’s procedures ; 
 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 Good Manufacturing Practice documents will provide adequate information to determine whether 
respective statutory and regulatory requirements of the authorities have been fulfille d. For 
greater certainty, “equivalence” does not require that the respective regulatory systems have identical procedures ; 
 Equivalent Authority  means an Authority in respect of which Swissmedic has made a positive 
equivalence determination according to the criteria and procedures specified in Annex 3 and as 
referred to in the Switzerland laws and regulations listed in Annex 1;  
 Good Manufacturing Practice (GMP)  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.  GMP include s strong qua lity 
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;  
 GMP inspection  means an inspection of manufacturing facilit ies, including processing, 
packaging, testing, and sterilizing  facilities , and contract facilities performing these functions , 
during the marketing of products for compliance with GM P; 
 
Inspection  means an on -site evaluation of a manufacturing facility to determine whether the
 
manufacturing facility is operating in compliance with GMP, its commitments made as part of 
the approval to market a product, or both;  
 Inspection Report  means a report written by an investigator or inspector of an Authority 
concerning an inspection of a manufacturing facility that the investigator or inspector  conducted 
that describes the purpose , scope , and details concerning the coverage of an inspection and 
includes written observations  or factual findings bearing on the manufacturing facilit y’s 
conformance to applicable GMP requirements
 set out in the laws  and regulations  listed in 
Annex 1 and any  commitments made as part of the approva l to market a product;  
 
Official GMP document  means a document issued by a n Authority following an inspection of 
a manufacturing facility.  Examples of official GMP documents include:  inspection reports ; 
certificates issued by an authority attesting the compliance of a manufacturing facility with 
GMP; GMP non- compliance statement s issued by Swissmedic ; and notices  of observation, 
untitled letters, warning letters, and import alerts issued by FDA ; 
 
Post-approval inspection  means an inspection  of a manufacturing facility  specific to an 
approved application; and  
 
Pre-approval inspection  means an inspection of a manufacturing facility carried out  as part of 
the review of an application before a marketing approval  is granted .      
 Article 2 :  Purpose  
 
This Agreement facilitates the exchange of official GMP documents between the 
Authorities  and reliance on the
 factual findings contained in those documents .2  This Agreement 
seeks to benefit public health and facilitate trade by  allowing each Authority to leverage and to 
reallocate its inspection resources, including by avoiding duplication of inspections, so as to 
improve each Authority’s  oversight of manufacturing facilities overall and better address  
quality risk and prevent adverse health consequences.  
  
Article 3:  Scope of the Agreement  
 1.  The provisions of this Agreement apply to:   
 
(a) pre-approval , post -approval , and GMP inspections  of manufacturing facilities  
conducted within the territory of a Party  by an Authority; and  
 
(b) pre-approval, post -approval, and GMP inspections  of manufacturing facilities 
conducted in territories of non- parties by an Authority to the extent provided for 
in paragraphs 3 and 4 of Article 5.  
 
2.  The provisions of this Agreement apply to inspections with respect to  those products 
described in  Annex  2. 
 
3. Annex 1 lists the laws  and regulations governing inspections and the GMP 
requirements.  
 
 
Article 4:  Recognition of Authorities  
 1.  For the purposes of this Agreement , the United States  recognizes  Swissmedic as a 
Capable A uthority according to the criteria and procedure specified in Annex  3.  
 2.  For the purposes of this Agreement, Switzerland recognizes the FDA as an Equivalent 
Authority according to the criteria and procedure specified in Annex 3.  
  
Article 5 :  Acceptance of  Official GMP Documents
 
 
1. Except as provided for in paragraph 2, with regard to manufacturing facilities located in 
the territory of a Party, the Authority of the other Party shall  recognize pharmaceutical 
inspections and accept  the official GMP documents  of an inspection of a manufacturing facility 
conducted by the other Authority.   2. In specific circumstances , an Authority may decide  not to accept an official GMP 
document as provided for in paragraph 1.  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.   
 
 
2 Pursuant to 21 U.S.C. § 384e, FDA has the authority to enter into agreements to recognize pharmaceutical 
inspections conducted by foreign regulatory authorities, including relying upon information from such inspections, 
if FDA determines those authorities are capable of conducting inspections that meet U.S. requirem ents.     3.  Each  Authority may accept official GMP documents issued by the Authority  of the other 
Party  for manufacturing facilities located outside the territory of the Party of the issuing 
Authority. 
 
4. Each  Authority may determine the terms and conditions under which it accepts official 
GMP documents  under paragraph 3.  
 5. For purposes of this Agreement , to accept an official GMP document means to rely on 
the factual  findings in such document  and to take the conclusions of the issuing Authority into 
account . 
  
Article 6 :  Transmission of O fficial GMP D ocuments  
 
1. If an Authority requests an official GMP document from the  Authority of the other 
Party, the requested Authority shall transmit the requested document  within 21 calendar days 
of the request or of the requested document being finalized, whichever is later .   
 
2.  The Authority that decides not to accept an official GMP document shall notify the 
issuing Authority of the reasons for non -acceptance and may request clarification from that 
issuing Authority.  The issuing Authority shall respond to a  request for clarificatio n in a timely 
manner and shall normally base its response on input  from one or more members of the 
inspection team.  
 
3. If, based on an  official GMP document, the requesting Authority determines that another 
inspection of the manufacturing facility is needed , the requesting Authority may request:  
 
(a) the Authority of the other Party to conduct an inspection in accordance with 
Article 7; or  
 
(b) additional inspection reports from the other Authority. 
 
 Article 7 :  Requests for Pre-approval , Post -approval, and GMP I nspections  
 1. Each Authority may request  in writing , after assessing the official GMP documents of 
the other Party , if available,  and concluding that another inspection is necessary , that the 
Authority of the other Party conduct a pre- approval, post -approval, or GMP inspection of a 
manufacturing facility.  The
 written request shall include the reason for the request and identify 
the precise issues to be addressed in the  inspection and the requested time line for completing 
the inspection and transmitting the official  GMP documents. 
 2. Within 15 calendar days of receipt of the request, the requested  Authority shall 
acknowledge receipt  and confirm whether it will conduct the inspection in accordance with the 
requested timelines.  If the requested  Authority considers that final official GMP documents 
relevant to the
 request are available, it shall notify the requesting Authority and  trans mit any 
final official GMP documents upon request . 
  
Article 8 :  Safeguard Clause  
 
1. Each Party  recognizes that the importing Party  has a right to fulfil l its legal 
responsibilities by taking actions necessary to ensure the protection of human and animal health 
at the level of protection it deems  appropriate.  
     2. Further to paragraph 1, e ach Authority has the right consistent with the other Party’s 
applicable laws, to conduct its own inspection of a  manufacturing facility  in the territory of the 
other Party, including whe n the Authority of the other Party has declined to conduct its own  
inspection.  
 3. An Authority conducting its own inspection of a manufacturing facility in the territory 
of the other Party should be an exception from the normal pr actice.  
 4. An Authority conducting its own  inspection of a manufacturing facility in the territory 
of the  other Party shall notify  in writing the Authority of the other Party p rior to  conducting the 
inspection.  The written notification  shall include the reason for the inspection and identify the 
issues to be addressed in the inspection and the requested timeline for the inspection.   5. In the event that an Authority conducts an inspection referred to in  paragraph 4, the 
requested Autho rity of the other Party may join that inspection. 
  Article 9 :  
Suspension of an Authority  
 1. Each  Authority has the right to suspend recognition of the A uthority of the other Party.  
This right shall be exercised in an objective and reasoned manner . 
 2. If an Authority suspends  the recognition of the  Authority of the other Party, it shall , 
without undue delay, notify the suspended A uthority  of the reasons for the suspension and 
provide sufficient detail to allow the suspended Authority to understand corrective measures 
that must be taken to lift the suspension.  The Joint Committee of the Parties shall be informed thereof.  
 3. An Authority is  not obligated to accept an official GMP document  issued after the date 
of suspension from  the suspended A uthority.   
 4. A suspension shall remain in effect until the
 Authority lifts the suspension based on a 
positive determination of recognition made pursuant to a reassessment in accordance with the criteria specified in Annex  3. 
 
5. An Authority suspending the recognition of the Authority of the other  Party  shall, upon 
request , promptly discuss in the Joint  Committee of the Authorities :  
 
(a) the reason for the suspension; and  
 (b) the corrective actions that would need to be taken
 for the suspension to be lifted.    
 
6.  The Joint Committee of the Authorities  shall endeavor to discuss within three months 
of the suspension the appropriate timeframe and exact steps to be taken to lift the suspension 
based on a positive determination of recognition made pursuant to a reassessment in accordance 
with the criteria specified in Anne x 3.  
 
 Article 1 0:  Exchange of I nformation  
 
The Authorities of each Party shall establish appropriate arrangements, including access 
to relevant databases, for the
 exchange of : 
 
(a) official GMP documents ;  
     (b) other appropriate information related to the inspection of a  manufacturing 
facility ; or 
 
(c) any information concerning confirmed problem reports, corrective actions, 
recalls, rejected import consignments, and other regulatory and enforcement problems  for products covered by  this Agreement . 
 
 Article 1 1:  Alert System 
 
Each Authority shall maintain an a lert system that permits the Authority of the other 
Party to be  made aware, proactively and with the appropriate speed, of:  
 
(a) quality defects  as outlined in the Pharmaceutical Inspection  Co-operation 
Scheme ( PIC/S ) Procedure for Handling Rapid Alerts and Recalls Arising from 
Quality Defects  Standard Operating P rocedure dated 1 July 2017, as amended ; 
 
(b) recalls  as outlined in the PIC/S Procedure for Handling Rapi d Alerts and Recalls 
Arising from Quality Defects  Standard Operating P rocedure dated 1 July 2017, 
as amended ; 
 
(c)  counterfeit or
 falsified products  as outlined in the PIC/S Procedure for Handling 
Rapid Alerts and Recalls Arising from Quality Defects  Standard Operating 
Procedure dated 1 July 2017, as amended ; or  
 
(d) potential serious shortages and other problems concerning quality or non-compliance with GMP  that could necessitate additional controls or suspension 
of the distribution of the affected  products . 
  Article 1 2:  Transitory Provisions  
 1.  No later than 12 months  following the entry into force of this Agreement , the Joint 
Committee of the Authorities  shall review experience gained , including timelines for sharing 
GMP documents, in order to consider whether the provisions on pre - and post -approval 
inspections provided in th is Agreement  shall be reviewed.  The Joint Committee of the 
Authorities  may decide to postpone this review.  
 2.  No later than  three years following the entry into force  of this Agreement , the Joint 
Committee of the Authorities  shall consider  whether to include vaccines for human use within 
the product coverage of this Agreement.   
 3. Without prejudice to the  consideration identified in paragraph 1 and 2, as of the entry 
into force  date of this Agreement , an Authority shall notify the Authorit y of the other Party in 
advance of conducting a pre -approval, post-approval , or GMP  inspection of a manufacturing 
facility of vaccines for human use  located in the territory of the Party and give the Authority of 
that Party  the option of joining the inspection.  In order to support the inclusion of vaccines for 
human use within the product coverage of this Agreement , the Joint Committee of the 
Authorities  shall take into account, in particular, the experience gained through such 
inspec tions.  
 
4. Either at the time of the initial consideration identified in paragraph 2, or thereafter, the 
Joint Committee of the Authorities may decide to include vaccines  for human use  within the 
product coverage of this Agreement .  If the Joint Committee  of the Authorities makes such a 
decision, it will promptly refer the matter  to the Joint Committee of the Parties with a view to 
amend Annex 2 in accordance with Article 17.       
5. In the event that Annex 2 is amended pursuant to paragraph 4, the respective Authorities 
shall, without undue delay, make the amended text publicly available on their respective websites.  
  
Section B :  Administrati on and Enhancement  of the Agreement  
 Article 1 3:  Changes to Laws, Regulations , and Criteria  
 1. Each Party shall notify the other Party of a change to its laws related to this Agreement, 
including those laws listed in Annex 1, as soon as practicable.  Annex 1 shall be amended 
accordingly, if necessary . 
 2. Each Party shall notify the 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 environmental protection requi re more 
urgent action, the Party  shall notify the other Party of the change as soon as practicable.  Annex 
1 shall be amended accordingly, if necessary . 
 3. Each Party  shall notify the other Party of any significant changes that may have an 
impact on the criteria for recognition  as soon as practicabl e. 
  Article 14 : Joint Committee of the Authorities
 
 1. The Parties hereby establish a Joint Committee of the Authorities  to facilitate 
communication between Authorities  and the effective operation of th e Agreement.   
 2. The Joint Committee of the Authorities  shall be co -chaired by representatives  from the 
Authorit y of each Party .  The Joint Committee of the Authorities  shall make its decision s by 
unanimous consent.  The Joint Committee of the Authorities  shall determine its own rules and 
procedures.  
 
3. The Joint Committee of the Authorities  shall provide  a forum to discuss any issue 
relating to the operation of this Agreement, and it s functions shall include  the following:  
 
(a) providing a forum to discuss  issues regarding recognition or suspension and 
timelines for completing assessments or reassessments according to the criteria specified  in Annex 3;  
 (b) adopting, where necessary, appropriate  complementary technical and 
admin istrative measures  for the effective implementation of this Agreement;  
 
(c) resolving issues that may arise concerning the implementation of this 
Agreement ; 
 (d) considering ways to enhance the operation of this Agreement;  and 
 (e) considering w hether to amend this Agreemen t. 
 
4. The Joint Committee of the Authorities  shall meet at the request of one of the 
Authorities with respect to disagreements between the Authorities, including determinations of 
recognition or suspension, at such  times as this committee  may agree.   
     5. The Joint Committee of the Authorities  may meet in person or by other means as agreed 
to by this committee . 
 
 
Article 15 :  Joint Committee of the Parties (“Joint Committee”)  
 1. The Parties hereby establish a Joint Committee . 
 2. The Joint Committee shall be composed of government representatives of each Party, 
including representatives from each Authority .  It shall be co -chaired by both Parties.  The Joint 
Committee  shall make its decisions by unanimous consent.  It shall determine its own rules and 
procedures.  
 
3. The Joint Committe e may consider any matter relating to this Agreement .  In particular , 
its functions  shall include  the following:  
 
(a) considering any ma tter referred by the Joint Committee of the Authorities, as 
listed under paragraph 3 of Art icle 14; 
 
(b)  considering trade facilitating measures and the impact on small-  and medium -
sized businesses ; 
 
(c) resolving issues that may arise concerning the implementation of this 
Agreement;  
 
(d) noting decisions of the Joint Committee established under Article 14 of the 
Agreement on mutual recognition between the European Community and the United States of America  with respect to matters that relate to this Agreement;  
and 
 (e) considering whether  to amend or terminate the Agreement , including any 
Annexes.  
 
4. The Joint Committee may meet in person or by other means as agreed t o by this 
committee .  
  Article 16 :  Other Agreements  
 
1. Except where there is written agreement between the Parties, obligations contained in a 
mutual recognition agreement  or any other  agreement  between a Party and a non- party shall 
have no effect with regard to the other Party.  
 
2. This Agreement shall not affect the rights and obligations of the Parties under any 
other international agreement.  
  Article 17 :  Entry into Force, Amendment, and Termination  
 
1. Each Party shall notify the other Party, in writing, once its Authority  has:  
 
(a) completed  the assessments according to the criteria and procedure specified in 
Annex 3; and  
 
(b) positively recognized the Authority of the other Party pursuant to Article 4, 
     and the Party has completed the  internal procedures required for the entry into force of this 
Agreement.   
 
2. This Agreement shall enter into force the day following the last notification.  
 3. This Agreement may be amended by written agreement of the Parties.  
 4. Annexes of this Agreement shall form an integral part thereof.  T he Joint Committee  
may decide to amend an Annex.  
 5. Either Party may terminate this Agreement by providing the other Party six months’ 
notice in writing.    6.  The Parties shall continue , after termination of this Agreement,  to recogni ze official 
GMP documents issued in accordance with, and prior to the expiry of, this Agreement, provided that the GMP documents were issued before the notice of termination  was provided. 
 
      ANNEX 1 
 
Applicable Laws  and Regulations  
 
 The applicable laws  and regulations  for each Party are as follows:  
  (a) For Switzerland : 
 
(i) Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA, SR 812.21).  Of particular relevance: Chapter 2 (Medicinal Products) Section 1 (Manufacture) Art. 5, 6, 7; Section 3 (Imports, Exports and Foreign Trade) Art.18 et seqq.;  Chapter 4 
(Common Provisions on Medicinal Products and Medical Devices), 
Section 3 (Market Surveillance and Inspection Procedures) Art. 58, 60;  
 
(ii) Ordinance on Licencing in the Medicinal Products Sector (Medicinal 
Products Licencing Ordinance, MPLO, SR 812.212.1).  Of particular 
relevance: Chapter 2 (Establis hment Licences) Section 1 (Manufact uring 
Licence) Art. 3 et seqq.; Chapter 3 (Licensing Procedure) Art. 39 et 
seqq.; Chapter 6 (Implementation) Section 1 (Inspections) Art. 56 et seqq.; Section 2 (Collaboration between Swissmedic and Other Authorities) Art. 64; Annex 1 (International rules of Good 
Manufact uring Practice);   
  (b) For the United States:  
 
(i) 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, stren gth, quality, and purity of drug); 21 
U.S.C. 374 (inspection authority);  and 21 U.S.C. 384e  (recognition of 
foreign government inspections ); 
 
(ii) 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 al product  
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);  and 42 U.S.C. 262(j) 
(Feder al Food, Drug, and Cosmetic Act applies to biologic al products) ; 
 
(iii) 21 C .F.R. Part 210 (Current Good Manufacturing Practice in 
Manufacturing, Processing, Packing or Holding of Drugs; General) ; 
 
(iv) 21 C .F.R. Part 211 (Current Good Manufacturing Practice for Finished 
Pharmaceuticals) ; and  
 
(v) 21 C .F.R. Part 600, Subpart B (Establi shment Standards) and Subpart C 
(Establishment Inspection) .     ANNEX 2 
 
List of Products Covered by this Agreement  
 
1. To the extent described  in paragraphs 3 and 4, t he provisions of this Agreement apply 
to finished pharmaceuticals for human or animal use, intermediates , in-process materials (as 
defined  under U.S. regulations ), certain biological products for human use, and active 
pharmaceutical  ingredients . 
 2.
 The list of products covered by the Agreement is provided in paragraph 4.   The laws 
and regulations  listed  in Annex 1 of each Party provide the definition of each  product  listed in 
paragraph 4 applicable in each Party.   
 
3. Notwithstanding any other provision of this Agreement, human blood, human plasma, 
human tissues , cells,  organs, and ve terinary immunologicals are excluded  from the scope of this 
Agreement.  
 4. The following products are covered by this Agreement : 
 
(a) marketed finished pharmaceuticals for human use in various pharmaceutical 
dosage forms such as
 tablets, capsules, ointments, and injectables, including:  
 
(i) medical gases;  
 
(ii) radiopharmaceuticals or radioactive biological products;  
 
(iii) herbal (botanical) products*; and 
 
(iv) homeopathic products ; 
 
(b) the following m arketed biological products:  
 
(i) plasma deri ved pharmaceuticals;  
 
(ii) therapeutic biotechnology- derived biological products;   
 
(iii) allergenic products ; and 
 
(iv) vaccines for human use ***; 
 
(c) in-process materials (for the United States) and intermediates (for Switzerland ); 
 
(d) active pharmaceutical ingredients or bulk drug substance s; 
 
(e) investigational products (clinical trial material) **; and 
 
(f) veterinary products:  
 
(i) veterinary pharmaceuticals, including prescription and non- prescription 
drugs, with the  exclusion of veterinary immunologicals;  and 
 
(ii) pre-mixes for the preparation of veterinary medicated feeds ( for 
Switzerland ) and Type A medicated  articles for the preparation of 
veterinary medicated feeds ( for the United States ). 
     * These are included to the extent that they are regulated as drugs by FDA and medicinal 
products by  Switzerland . 
 
** Swissmedic conducts inspections of investigational medicinal products.  FDA does not 
routinely conduct GMP 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 Agreement  to the 
extent the Joint Committee  of the Authorit ies decides to include them  and the Joint Committee 
of the Parties amends this annex  pursuant to Article 12. 
     ANNEX  3 
 
Criteria and Procedure for Assessments Under this Agreement  
 
I. Criteria for Assessments under this  Agreement:  
 Each Party will apply the following criteria to determine whether to recognize an A uthority:  
 
(i) The Authority has the legal and regulatory authority to conduct inspections 
against a
 standard for GMP ; 
 (ii) The A uthority manages conflict of interest in an ethical manner ; 
 (iii) The A uthority has the ability to evaluate risks and mitigate them;  
 (iv) The Authority maintains appropriate oversight of manufacturing facilities within 
its
 jurisdiction ; 
 (v) The A uthority has and uses sufficient res ources ; 
 (vi) The Authority employs trained and qualified inspectors with the skills and 
knowledge  to identify manufacturing practices that may lead to patient harm; 
and 
 (vii)  The Authority has the tools necessary to take action to protect the public from 
harm due to
 poor quality drugs or medicinal products. 
 II. Procedures for Assessment under this  Agreement  
 A. Assessment of Swissmedic by FDA  
 
1. To receive a capability assessment for an authority, Swissmedic  shall  submit 
capability assessment packages containing the following materials before FDA 
will initiate an assessment: 
 
(i) a finalized PIC/S audit report of an audit  or assessment reports provided 
by a non- party with which  Switzerland  has an agreement .  Such 
information should include  any associated corrective measures and all 
documents cited by the auditors in
 the report for 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 FDA signed by a principal  of Swissmedic ; 
 
(iii) a total of four inspection reports including the report from the inspections observed by FDA ; 
 
(iv) standard operating procedures or a description of how the authority finalizes inspection
 reports , including inspection reports of foreign 
facilities ; 
 
(v) standard operating procedures related to training and inspector qualification, in cluding training files  and ongoing competency     evaluations for all inspectors who conducted the inspections in the 
reports provided to  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  
Agreement , and upon request, completion of a table provided by FDA 
detailing types of manufacturing facilities.  
 
2.  FDA observed inspections  representative of the  different regions , if 
applicable . 
 
3.  During a capability assessment, FDA may require additional  or alternative  
information or further clarification from Swissmedic . 
 4. FDA may waive the requirement to submit certain information listed under II .A 
of this Annex.  The  decision to waive any
 assessment materials will be made by 
FDA on a case- by-case basis.  
 
B. Assessment of FDA by Swissmedic  
 
1. To receive an equivalency assessment for an authority, FDA shall submit 
equivalency assessment packages containing the following materials before Swissmedic will initiate an assessment:  
 (i) a finalized PIC/S audit report of an audit  or assessment reports provided 
by a non-party with which  the United States  has an agreement.  Such 
information should include  any associated corrective measures and all 
documents cited by the auditors in
 the report for the indicators as 
identified by Swissmedic  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 
Swissmedic  signed by a principal  of FDA ; 
 
(iii) a total of four inspection reports including the report from the inspections 
observed by Swissmedic ; 
 
(iv) standard operating procedures or a description of how the authority 
finalizes inspection  reports, including inspection reports of foreign 
facilities ; 
 
(v) standard operating procedures related to training and inspector 
qualification, including training files  and ongoing competency 
evaluations for all inspectors who conducted the inspections in the 
reports provided to  Swissmedic  (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  
Agreement, and upon request, completion of a table provided by Swissmedic  detailing types of manufacturing facilities.  
 
2.  Swissmedic observed inspections representative of the type of inspections, if applicable.       
3. During an equivalency assessment, Swissmedic  may require additional  or 
alternative  information or further clarification from FDA.  
 
4. Swissmedic  may waive the requirement to submit certain information listed 
under II.B of this Annex.  The  decision to waive any  assessment mater ials will 
be made by Swissmedic  on a case -by-case basis.  
 C. Reassessment of an A uthority  
 
An Authority may reassess the other Authority to maintain  ongoing status of each A uthorit y’s 
capability or i n the event an Authority issues a suspension or negative determination of a n 
Authority.  In the event of a suspension or negative determination, t he scope of the reassessment 
shall relate to the reasons
 for the suspension or negative determination.  
 III. Maintaining Recognition 
 
To maintain recognition, the recognized A uthority must continue to meet the criteria set out in  
section  I of this Annex.  In case a recognized  Authority has not been subject to a  PIC/S  
reassessment  for a period of six years, the recognizing Authority shall have the right to audit 
the recognized  Authority.