Common Technical Documets
The common technical document (often abbreviated as CTD) was developed by the ICH (International Conference on Harmonization) working group with representatives from regulatory bodies in Europe, Japan and the United States. The CTD is a set of specifications for the submission of regulatory data in the application for the right to market pharmaceuticals. The format of the common technical document is not to be confused with its content or submission type; rather, it is the means by which information in a submission is organized. The eCTD (electronic CTD) is the fully electronic application message which is most commonly used for regulatory submissions.
1. Introduction
The Common Technical Document for Registration of Pharmaceuticals for Human Use(International Conference on Harmonisation [ICH] Topic M4) was adopted by Health Canada, in 2003, for use in the preparation of drug regulatory activities (submissions and applications).
The Common Technical Document (CTD) provides a globally harmonised format that is accepted in many regions, avoiding the need to compile different registration dossiers for different regulatory authorities. It is organized into five modules. Module 1 is region specific, while Modules 2, 3, 4, and 5 are intended to be common for all regions. A regional component is included in Module 3. The review of information provided in a well structured regulatory activity will improve the efficiency of the screening and review of that regulatory activity.
This guidance document has been updated to facilitate the use of a common format for the filing of regulatory activities and the management of information over the lifecycle of a product. Once finalized, this guidance document will supersede the 2003 Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format and all other references to the layout of Modules 1 and/or 3.2.R, where extensive changes have been made to provide placeholders for regional documents throughout the lifecycle of the product.
It is important to note that the implementation and use of the CTD represents a work in progress, and it is expected that future refinements of this guidance will continue to be necessary as a result of experience gained. Amendments will also be undertaken as a result of the migration to and implementation of the eCTD.
1.1 Policy Objective
To facilitate the preparation of a drug regulatory activity, pursuant to Part C of the Food and Drug Regulations, in the CTD format.
1.2 Policy Statement
The Food and Drug Regulations provides regulatory requirements for the approval and sale of drugs in Canada and prohibits the sale of drugs unless the manufacturer has filed a regulatory activity that is satisfactory to the Minister. Although the regulations do not define format requirements, Health Canada has adopted the CTD format within the Canadian registration framework. This guidance document, once finalised, is to be used in the preparation of drug regulatory activities for human use filed to Health Canada.
1.3 Scope and Application
This guidance document applies to the preparation of all drug regulatory activities for human use, filed pursuant to the Food and Drug Regulations, including Clinical Trial Applications (CTA), their amendments (CTA-A) and Drug Master Files (DMF).
The CTD format is the expected format for all drug regulatory activities including drug/device combinations where the primary mechanism of action is drug-related. For cases where the combination product is classified as a device, the use of the CTD format for the drug component is encouraged. For medical devices, please see Summary Technical Document for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED), developed by the Global Harmonization Task Force (GHTF).
2 Guidance for Implementation
This document outlines the CTD format for the submission of information in relation to drugs for human use, which is filed over the lifecycle of that product in Canada. Table 1provides an overview of the presentation of the drug regulatory activity, outlining the modular structure and main headings, which should be used.
The CTD format also provides the structure for the eCTD format; therefore some documents are specific to the format in which a regulatory activity is submitted. For example, the Table of Contents is only required in the CTD format, where the Life Cycle Management Table is only required in the eCTD format.
The first draft of the CTD Guidance (2003) was for the use of the CTD format with New Drugs Submission (NDS) regulatory activities only. With this guidance, Health Canada as moved to a more inclusive approach for the CTD format, with the inclusion of documents that may only be submitted for specific regulatory activity types or upon request; therefore many sections and subsections may not be applicable for a given regulatory activity. When no information is required in a specific section or subsection, that section or subsection should be omitted. A rationale for the absence of information may be required and should be provided as a note to reviewer. The numbering of an omitted section should not be reused for another section.
The CTD Guidance indicates where and how available information is to be presented; however, it is not intended to indicate what is actually required. Therefore, when preparing a regulatory activity, it is necessary to consult relevant Health Canada guidance documents (including the adopted ICH guidelines) on technical (data) requirements. Applicants are advised to consult the Health Canada website for the latest updates on guidance documents.
This guidance is intended to be used in conjunction with the most recent version of the following documents:
ICH CTD guidelines and the corresponding Questions and Answers documents on the ICH website;
The accompanying Health Canada Notice for supplementary and/or interim guidance; and
Related Health Canada guidance documents and notices on Quality and comparative bioavailability information.
For additional guidance, the applicant should consult the appropriate review Bureau in the Therapeutic Products Directorate (TPD) or the Office of Regulatory Affairs in the Biologics and Genetic Therapies Directorate (BGTD).
Table 1: Presentation of Information in the Common Technical Document (CTD) Format
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Module Number
|
Title and Main Section Headings
|
Cross-Reference to Modules
|
Binder/ Label colour
|
Number of Paper Copies
|
 For combination products that require a joint review an additional copy of Modules 1, 2, and 3 is required. | ||||
1
|
Administrative and Product Information
|
2, 3, 4 and 5
|
Red
|
1
|
1.0
|
Correspondence
| |||
1.1
|
Table of Contents (Modules 1 to 5)
| |||
1.2
|
Administrative Information
| |||
1.3
|
Product Information
| |||
1.4
|
Health Canada Summaries
| |||
1.5
|
Environmental Assessment Statement
| |||
1.6
|
Regional Clinical Information
| |||
1.7
|
Clinical Trial Application and Clinical Trial Application- Amendment Specific Requirements
| |||
1.A
|
Appendix
| |||
2
|
Common Technical Document (CTD) Summaries
|
Yellow
|
1
| |
2.1
|
CTD Table of Contents (Modules 2 to 5)
|
2 to 5
| ||
2.2
|
CTD Introduction
|
2 to 5
| ||
2.3
|
Quality Overall Summary
|
3
| ||
2.4
|
Nonclinical Overview
|
2 and 4
| ||
2.5
|
Clinical Overview
|
2 and 5
| ||
2.6
|
Nonclinical Written and Tabulated Summaries
|
2 and 4
| ||
2.7
|
Clinical Summary
|
5
| ||
3
|
Quality
|
Blue
|
1
| |
3.1
|
Table of Contents of Module 3
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3.2
|
Body of Data
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3.3
|
Literature References
| |||
4
|
Nonclinical Study Reports
|
Green
|
1
| |
4.1
|
Table of Contents of Module 4
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4.2
|
Study Reports
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4.3
|
Literature References
| |||
5
|
Clinical Study Reports
|
Black
|
1
| |
5.1
|
Table of Contents of Module 5
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5.2
|
Tabular Listing of All Clinical Studies
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5.3
|
Clinical Study Reports
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5.4
| Literature References | |||
3.1 Module 1: Administrative and Product Information
Module 1 identifies placeholders, defined by the numerical items listed in the Module 1 Table of Contents (ToC), for all administrative and product information documentation. Sponsors should use their own discretion based on the number of documents being provided in a given folder in order to decide if those documents should be organized using subfolders.
Module 1.0 Correspondence
All correspondence-related documents submitted to Health Canada are to be placed in Module 1.0 unless otherwise indicated. Scientific information is not to be included in this Module.
Module 1.0.1 Cover Letter
Any data being submitted to Health Canada should be accompanied by a cover letter. The cover letter should clearly state what is being submitted, including reference to the request letter (if applicable) and a brief description of the package. For example, if a Periodic Safety Update Report (PSUR) is being submitted, one of the following types should be indicated in the cover letter:
Requested AD HOC PSUR - submitted as a one-time request (the requestor should be specified in the cover letter);
Voluntary PSUR - unsolicited information
Requested Periodic PSUR - requested by Health Canada, for example (e.g.) follow-up to a Risk Management Plan (RMP) or post-authorization commitment;
PSUR-C (confirmatory) - submitted to support the fulfilment of a Notice of Compliance with Conditions (NOC/c).
The cover letter should not contain any scientific information. The Question and Answer (Q and A) responses from Health Canada issued correspondence and the Note to Reviewer are assigned a specific location (1.0.4 and 1.0.7) and should not be included in the cover letter.
Any cross-referenced regulatory activity should be clearly stated in the cover letter, and the following information should be included:
regulatory activity type;
control number;
brand name;
manufacturer / applicant's name;
Central Registry (CR) file number;
Date the regulatory activity was approved.
Module 1.0.2 Life Cycle Management (LCM) Table
The Life Cycle Management (LCM) Table is a specific requirement for filing a regulatory activity in eCTD format, and should be placed in this section.
Module 1.0.3 Copy of Health Canada Issued Correspondence
A Copy of the Health Canada issued correspondence being responded to should be placed in this section. This includes (but is not limited to) the following:
Clarifax (during screening or review);
Notice of Deficiency (NOD);
Notice of Non-Compliance (NON);
Not Satisfactory Notice (NSN);
Post-Notice of Compliance Letters (Post-NOC);
No Objection Letter (NOL) comments;
Screening Deficiency Notice (SDN).
Module 1.0.4 Health Canada Solicited Information
Solicited information is defined as information requested by Health Canada. Responses to these requests are to be provided in Question and Answer format, and placed in this section. The answers should summarize the response and cross-reference the supporting data that is to be placed in the appropriate Module of the regulatory activity. No supporting data is to be provided in this section.
Module 1.0.5 Meeting Information
Any meeting related information and documentation, with the exception of Pipeline and Reconsideration meetings, are to be placed in this section. This includes (but is not limited to) the following:
meeting information package;
proposed meeting agenda;
presentation slides;
meeting minutes.
Module 1.0.6 Request for Reconsideration Documentation
Any documentation required as part of the Request for Reconsideration process is to be placed in this section.
Module 1.0.7 General Note to Reviewer
The Note to Reviewer should be used to facilitate the review. These comments are NOTto be included in the cover letter.
Notes relating to the entire regulatory activity (e.g., advising that the product is referred to by a foreign trade name throughout the regulatory activity) should be placed in this section.
Notes relating to a specific section of the regulatory activity should be placed at the beginning of each pertinent section. For example, this note can be used to identify changes in a section and/or document.
Module 1.1 Table of Contents (ToC)
The Table of Contents (ToC) for the entire regulatory activity should be placed in this section. It should list all documents included in Modules 1-5.
Module 1.2 Administrative Information
Module 1.2.1 Application Forms
Completed and signed application forms should be placed in this section.
Module 1.2.2 Fee Forms
Completed fee forms should be placed in this section.
Module 1.2.3 Certification and Attestation Forms
Completed and signed forms are to be placed in this section. These include, but are not limited to, the following:
Submission Certification Form
Required as per section C.08.005.1 of the Food and Drug Regulations. The use of company letterhead is preferred. Please see the Health Canada website for an example of appropriate wording.
To be signed and dated by the senior executive officer of the manufacturer in Canada and the medical or scientific director of the manufacturer. If the submission certification or any significant part of the certification was prepared by an agent authorized by the manufacturer, the submission certification must also be signed by that agent.
Responses to Screening Deficiency Notices, Notices of Noncompliance and Notices of Deficiency should include a revised submission certificate signed and dated as described above.
Letter of Attestation
To be included for any regulatory activity that includes both paper and electronic versions of information, confirming that the content contained in the electronic regulatory activity is identical to the paper-based regulatory activity.
Submission Disclosure Form (BGTD only)
Certification of Electronic Signature (placeholder)
Changes in Manufacturer's Name and/or Product Name Administrative Changes - Certification Form
Attestation of Pristine Product Monograph
Product Monograph Translation Certification Form
Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy (TSE) Attestation Form
Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM)
Application Certification Form
Statement of Commitment for Drug Master Files (DMF)
Module 1.2.4 Intellectual Property Information
Module 1.2.4.1 Patent Information
As per the Patented Medicines (Notice of Compliance) Regulations (PM (NOC) Regulations), an applicant (that is [i.e.] first person) who files or who has filed a new drug submission or a supplement to a new drug submission may submit a patent list in relation to the submission or supplement for addition to the Patent Register by filing a Form IV: Patent List within the time limits and according to the conditions set out in section 4 of the PM (NOC) Regulations.
A second person (i.e. subsequent entrant) must address all patents listed on the Patent Register for the Canadian reference product used to establish bioequivalence for the second person's submission by filing a Form V: Declaration Re: Patent List as per section 5 of the PM (NOC) Regulations. Documents relating to the Notice of Allegation, including proof of service and the Acknowledgement and Certification of Receipt of Information and Material form, are also to be placed in this section.
Module 1.2.4.2 Data Protection Information
C.08.004.1 of the Food and Drug Regulations provides a term of data protection to manufacturers of innovative drugs during which the Minister shall not approve a subsequent entry submission submitted for a new drug on the basis of a comparison between the new drug and the innovative drug. The term of data protection is effective from the date of the issuance of the Notice of Compliance (NOC) and extends to eight years (eight and one-half years if relevant paediatric clinical trial data is submitted). Innovative manufacturers may place information that supports the eligibility of their innovative drug for data protection in this section.
Module 1.2.5 Compliance and Site Information
Module 1.2.5.1 Clinical Trial Site Information Forms
Completed Clinical Trial Site Information Forms (CTSI) must be provided in this section for each proposed clinical trial site.
Module 1.2.5.2 Establishment Licensing
Establishment Licensing (EL) information should be placed in this section.
Module 1.2.5.3 Good Clinical Practices
Good Clinical Practices (GCP) related documentation should be placed in this section.
Module 1.2.5.4 Good Laboratory Practices
A statement of GLP compliance consistent with the Organisation for Economic Co-operation and Development's (OECD) Principles of Good Laboratory Practice (GLP) should be placed in this section.
Module 1.2.5.5 Good Manufacturing Practices
Good Manufacturing Practices (GMP) compliance information should be placed in this section. This may include the Certificate of Compliance (COC) issued by the Health Products and Food Branch Inspectorate (HPFBI) when the foreign GMP rating is accepted for a foreign site under a Mutual Recognition Agreement (MRA).
Regulatory GMP compliance and EL status issued by other jurisdictions, including Date of last GMP and/or pre-approval inspection, and any observation-related information should also be placed in this section.
Module 1.2.5.6 Good Pharmacovigilance Practices
Good Pharmacovigilance Practices (GPP) related documentation should be placed in this section.
Module 1.2.5.7 Other Compliance and Site Information Documents
Any other regulatory compliance and site-related information which is not currently covered under Module 1.2.5.1-1.2.5.6 should be placed in this section.
Module 1.2.6 Authorization for Sharing Information
Letters authorizing Health Canada to share information regarding the regulatory activity with other regulatory authorities (or vice versa), and/or to access other (third party) drug regulatory activities, DMF and Site Reference Files (SRF) should be provided in this section.
Module 1.2.7 International Information
Information on the product application, approved indications and marketing status in other countries/regions provide useful contextual information should be provided in this section when requested. Depending upon the status this may include, but not be limited to, the following:
International registration, review and/or marketing status, including date of filing, approval of product or supplemental changes in other jurisdictions, information regarding the withdrawal, stop of sale and/or market recall;
Foreign refusals;
Foreign clinical trial status;
International Birth Date of the product and for all approved indications;
Confirmation of filing or the date(s) of approval or withdrawal;
Foreign review reports, including Question and Answer (Q and A) documents (upon request only);
Meeting minutes from other jurisdictions (upon request only).
Module 1.2.8 Post-Authorization Information
The following information should be included in this section:
Market Notification Forms
As per part C.01.014.3 of the Food and Drugs Regulations, companies are required to notify Health Canada of a drug being sold.
For labels see section 1.3.2
Post-Authorization Commitments
The commitment tracking table, as detailed in Appendix C should be provided here.
These commitments are intended for those outside of the NOC/c scope. For NOC/c related documents, see Module 1.6.4.
Notices of Change (Level III) forms
Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Forms are to be placed in this section. These forms should not be confused with the Annual Notification, which is not included in the scope of this document.
Notice of Decision and Summary Basis of Decision
All versions of the Notice of Decision and Summary Basis of Decision documents are to be placed in this section.
Module 1.2.9 Other Administrative Information
This section is for any administrative information that does not have a designated location in the CTD format. This section should NOT contain any scientific information.
Module 1.3 Product Information
Module 1.3.1 Product Monograph
A copy of the non-annotated (clean) and annotated Product Monograph are to be placed in this section. This includes both the pristine and second language PMs.
The text of the annotated copy at the time of filing should be cross-referenced to supporting information and study findings reported in Module 2 documents and, when submitted, the Bioequivalence Summary (Module 1.4.2). Applicants may also choose to include references to related information in Modules 3 to 5, as appropriate.
Within the sections of the annotated Product Monograph, the text should also be cross-referenced by number to the References or Selected Bibliography section at the end of the Product Monograph.
Articles from publications listed in the References section should be cited in accordance with the current edition of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, International Committee of Medical Journals Editors (ICMJE). When reference is made to a publication not provided in Modules 2 - 5, copies of the reference material should be provided in this section.
When revisions are requested during the course of the review, an annotated version of the revised Product Monograph is required. The annotations should reflect all changes made, either in relation to the last approved PM or in response to a request made from Health Canada.
Module 1.3.2 Inner and Outer Labels
All inner and outer labels should be provided in this section, including those submitted with the Market Notification.
This should include the labels for all strengths, dosage forms and reconstitution diluents. Typewritten or other draft label copy is acceptable for review purposes.
When additional revisions are requested during the course of the review, an annotated version of the revised label maybe requested, and should be placed in this section.
Module 1.3.3 Non-Canadian Labelling
If the drug product has been marketed outside Canada, the applicant is encouraged to supply the monograph or package inserts approved in other jurisdictions, clearly identifying them by country or region.
Module 1.3.4 Investigator's Brochure
Investigator's Brochure for CTA and CTA-As should be placed in this section.
Module 1.3.5 Reference Product Labelling
The Product Monograph for Canadian Reference Products is to be placed in this section.
Module 1.3.6 Certified Product Information Document
A copy of the non-annotated (clean) and annotated CPID are to be placed in this section. The text of the annotated copy at the time of filing should be cross-referenced to the corresponding sections of Module 3, while any further revisions should reflect all changes that have been made, including Level III changes. The clean version should not contain any cross-referencing.
Module 1.3.7 Look alike/Sound alike Assessments
The assessments are to be placed in this section.
Module 1.3.8 Pharmacovigilance Information
Module 1.3.8.1 Pharmacovigilance Plan
Pharmacovigilance plans or their equivalent are to be placed in this section.
Module 1.3.8.2 Risk Management Plan
Risk management plans or their equivalent are to be placed in this section.
Module 1.3.8.3 Risk Communications
Risk Communications are to be placed in this section.
Module 1.3.8.4 Other Pharmacovigilance Information
Any other pharmacovigilance information should be placed in this section.
Module 1.4 Health Canada Summaries
Module 1.4.1 PSEAT-CTA
The completed Protocol Safety and Efficacy Assessment Template - Clinical Trial Application should be placed in this section.
Module 1.4.2 Comprehensive Summary: Bioequivalence
The completed Comprehensive Summary: Bioequivalence (CS-BE) for all pivotal comparative bioavailability (bioequivalence) studies should be placed in this section.
Module 1.4.3 Multidisciplinary Tabular Summaries
This section is a placeholder for tables that contain information that is applicable to more than one discipline.
Module 1.5 Environmental Assessment Statement
An Environmental Assessment Statement is required for new substances in products regulated under the Food and Drug Act as per the New Substances Notification Regulations (NSN) of the Canadian Environmental Protection Act (CEPA). As per the New Substances Program Advisory Note 2006-04, New Substance Notification (NSN) packages for substances used in product regulated by the Food and Drugs Act must be submitted to the New Substances Division at Environment Canada.
Module 1.6 Regional Clinical Information
Module 1.6.1 Comparative Bioavailability Information
Specific requirements for pivotal comparative bioavailability (bioequivalence) studies should be placed in this section. These specific requirements include, but are not limited to:
Canadian Reference Product (CRP) Confirmation;
Requests for waivers and justification statements;
Verification of potency of the Test and Reference products (Certificates of Analysis);
Bioavailability/Bioequivalence (BA/BE) data sets (required for all types of pivotalcomparative bioavailability (bioequivalence) studies.
Module 1.6.2 Company Core Data Sheets
Company Core Data Sheets should be placed in this section.
Module 1.6.3 Priority Review Requests
All documents related to a Priority Review Request should be placed in this section only.
Module 1.6.4 Notice of Compliance with Conditions
All documentation relating to an NOC/c is to be placed in this section only. These documents include, but are not limited to, the following:
Letter of undertaking;
Qualifying Notice;
Dear Health Care Professional Letters (DHCPL);
Product Specific Fact Sheets.
Module 1.7 Clinical Trial Information
Module 1.7.1 Study Protocol
All required copies of the Study Protocol are to be placed in this section.
Module 1.7.2 Informed Consent Forms
The Informed Consent Forms are to be placed in this section.
Module 1.7.3 Canadian Research Ethics Board (REB) Refusals
Canadian Research Ethics Board (REB) refusals are to be placed in this section.
Module 1.7.4 Information on Prior-related Applications
Information on prior-related applications is to be placed in this section.
Module 1.A Appendix
Module 1.A.1 Electronic Review Documents
All electronic media submitted to support the drug regulatory activity should be placed in this section.
3.2 Module 2: Common Technical Document (CTD) Summaries
Please consult the ICH M4 Guidelines.
3.3 Module 3: Quality
Please consult the ICH M4Q Guidelines.
Module 3.2.R Regional Information
To complete the regional section of Module 3 the applicant should refer to the appropriate Health Canada CTD Quality guidance documents.
Module 3.2.R.1 Production Documentation
Module 3.2.R.2 Medical Devices
Module 3.2.R.3 Lot Release Documentation - BGTD
Module 3.2.R.4 Yearly Biologic Product Report (YBPR)-BGTD Only
The Yearly Biologic Product Report (YBPR), provided for BGTD only, is to be placed in this section.
3.4 Module 4: Nonclinical Study Reports
The applicant should refer to the ICH M4S guidelines, as well as the appropriate Health Canada guidance documents to complete this module.
3.5 Module 5: Clinical Study Reports
The applicant should refer to the ICH M4E guideline under Module 5: Clinical Study Reports, and the ICH E3 guideline, Structure and Content of Clinical Study Reports.
In addition, the applicant should note the following in relation to cited modules of the CTD:
Module 5.3.1.2 Comparative Bioavailability (BA) / Bioequivalence (BE) Study Reports
The technical requirements for pivotal comparative bioavailability (bioequivalence) studies are provided in the Health Canada Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format.
Module 5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
The technical requirements for pivotal comparative bioavailability (bioequivalence) studies are provided in the Health Canada Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format.
Module 5.3.6 Post Marketing Experience
Periodic Safety Update Reports (PSUR) should be placed in this section.
Module 5.3.7 Case Report Forms and Individual Patient Listings
Case report forms that are described as appendix 13.3.1 in the ICH clinical study report guideline (E3) should be placed in this section at the time of filing.
Appendices 16.3.2 (Other Case Report Forms (CRFs)) and 16.4 (Individual patient Data Listings) are to be sent promptly (within 2 business days) when requested.
All CRFs provided should be placed in this section, in the same order as the clinical study reports, and indexed by study. All CRFs are to be provided in electronic format only.
This section describes the physical specifications for submitting paper regulatory activity in CTD format. The paper format is to serve as the official Central Registry (legal) copy for paper-based regulatory activity.
The regulatory activity should be bound in three-ring binders.
Binders should be colour-coded as specified in Table 1. Alternatively, labels on the spines as well as on the cover are to be colour-coded as indicated.
The binder labels on the spine and the front cover should include the following information:
trade (brand) name of the drug product;
name of the manufacturer;
proper or common and code names;
sequential number, starting at Volume 1 for each module;
The volume number for that binder, out of the total number of volumes for that module, the section(s) contained within each volume, and the date of regulatory activity (month and year), should also be specified on the label.
For example, the label on a blue-coloured binder (Volume 1 of Module 3: Quality), would read as follows:
Drug Product "ABC"
Applicant/Manufacturer "XYZ"
Volume 1 of 63
3.1-3.2.S.2.3
Month/year
Note: In the case of Notifiable Changes (NCs) containing small amounts of information it is recommended, where possible, that all modules of the regulatory activity be provided in one (black) binder.
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