Section D. IMP Identification

Task topic including steps necessary for completing Section D. IMPAcronym: Investigational Medicinal Product. A pharmaceutical form of an active substance or placebo being tested or used as a reference in a Clinical Trial, including products already with a marketing authorisation but used or assembled in a different way from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. Identification of a Clinical Trial Application draft, concerning the identification of Investigational Medicinal Products to be used in the Clinical Trial, and their constituent active substances.

Complete all questions in Section D for each IMP, but if most of the answers are the same for any additional IMP(s) (e.g. 3 tablets of different strength), then enter one IMP, use the 'Copy IMP' function in the IMP Details screen, which appears once the first IMP has been added. You may then edit the relevant fields in the copy and update the information (e.g. Strength).

To Add an IMP
  1. Click 'Add IMP' to start the first Investigational Medicinal Product (IMP) or create another one.
  2. Fill out the details relating to the IMP in all the sub-sections of Section D.
  3. Once an IMP is added, it appears in the IMP Details' table:
    Tip: Click on the screenshot to view it full size and click on the various onscreen elements to learn more about the functionality of the screen.
Options for 'Edit IMP', 'Delete IMP', 'Copy IMP', and 'Add active substance' are displayed for that IMP, which can now be utilised. Additional IMPs may also be added, as necessary.

To continue completing the current IMP, it is recommended to search for an active substance in order to add it to the IMP Details.

To Add an Active SubstanceAn active substance (AS), is the substance in a medicine that is responsible for the expected effect of the medicine.(s) to this IMP, see "To Add an Active Substance(s) to this IMP"

Now see the following section for detailed information on completing the sub-sections.

D.1/D.2 IMP Identification and Status Details

Concerning information relating to the identification of the Investigational Medicinal Product(s) to be used in the Clinical Trial and the IMP's status.

Once the sub-section is complete click the Next button button at the bottom of the page to move to the next sub-section.
Use Next button at the foot of each screen to ensure completion of all questions in Section D.

Tip: Sections D.3.8 to D.3.10 are available via the 'add active substance' function.
NOTE: If there is no clear 'Test IMP' or 'ComparatorAn investigational or marketed product (i.e active control) or placebo, used as a reference in a Clinical Trial.' in your study design, indicate all Investigational Medicinal Products (IMPs) as 'Test IMP'.Each strength and pharmaceutical form should be recorded as a separate Investigational Medicinal Product (use "copy IMP" and edit the strength of each active substance and/or pharmaceutical form of the IMP).
  1. Choose the Investigational Medicinal Product Category from the drop-down list. Click the drop-down list to select relevant option (D.1.2 and D.1.3).
    2. Note: In Section D.2, the information provided should be that which specifically relates to the actual product being used in the trial in the Member State to which the CTAAcronym: Clinical Trial Application is addressed. For example, if the CTA is submitted in France, the IMPAcronym: Investigational Medicinal Product. A pharmaceutical form of an active substance or placebo being tested or used as a reference in a Clinical Trial, including products already with a marketing authorisation but used or assembled in a different way from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. has a MAAcronym: Marketing Authorisation in France and Germany, and the sponsor chooses to use the IMPAcronym: Investigational Medicinal Product. A pharmaceutical form of an active substance or placebo being tested or used as a reference in a Clinical Trial, including products already with a marketing authorisation but used or assembled in a different way from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. registered in Germany for the purposes of the trial, it is the German trade name/MAHAcronym: Marketing Authorisation Holder. The company named on the Marketing Authorisation for a specific product in a particular country./MAAcronym: Marketing Authorisation number that should be mentioned in this section.
  2. When you answer D.2.1, if you select the 'No' option then go to D.3.
    If 'Yes' then complete section D.2.1.1.1 to D.2.1.1.4.
    UNLESS the IMP has a Marketing AuthorisationThe approval granted by the Regulatory Authority to market a specific product in a particular country. in the Member State concerned by this application, but the trade name and marketing authorisation holder are not fixed in the protocol. In such a case, complete D.2.1.2 with the name of the Member State to which the application is submitted, answer 'Yes' to D.2.1.2.1, and then go to section D.2.2.
    3. Tip: If the Investigational Medicinal Product has a Marketing Authorisation in the Member State concerned by this application but the trade name and marketing authorisation holder are not fixed in the protocol, go to section D.2.2, below.
  3. If the IMP has a Marketing Authorisation in the country from which it is sourced for use in this Clinical Trial, please complete section D.2.1.1.with the information relevant to the country from which the product has been sourced.
  4. In free text field D.2.1.1.1, if the IMP has a Marketing Authorisation in the country from which it is sourced for use in this clinical trial, specify the Product Name as registered by the Marketing Authorisation Holder (MAHAcronym: Marketing Authorisation Holder. The company named on the Marketing Authorisation for a specific product in a particular country.). It is available from the Summary of Product Characteristics (SmPC)This is the product information document which is made available to all prescribing physicians in the EU for marketed products., or product labelling.
  5. In free text field D.2.1.1.1.1, specify the EudraVigilance Product Code here when available (obtained from Eudravigilance Medicinal Product Dictionary EVMPD).
  6. In free text field D.2.1.1.1.2, specify the Name of the Marketing Authorisation holder, which is available from the Summary of Product Characteristics (SmPC), or Product Labelling..
    Tip: For more information, see details in EudraPharm.
  7. In free text field D.2.1.1.1.3, specify the Marketing Authorisation number, which is issued when a Marketing Authorisation is granted in a MS. It is available from the Summary of Product Characteristics (SmPC) or Product Labelling.
  8. In section D.2.1.1.4:
    • Answer 'Yes' if there are any trial-specific operations that could affect the product quality, such as modification of the pharmaceutical form (e.g. over-encapsulation, colour, dilution, re-tableting for blinding etc.) or removal from the primary packaging and repacking (e.g. removal from a blister and putting in a bottle). If the blinding consists in over encapsulating tablets, trial specific coating (modified colour, or debossing), this information should be reported here.
    • Answer 'No' If the product has only been relabeled or repackaged.
  9. In section D.2.1.2, click the drop-down list to specify the name of the country where the holder was granted the Marketing Authorisation of the actual Investigational Medicinal Product to be used in the clinical trial in the Member State concerned by the application.
    • If the Investigational Medicinal Product has a Marketing Authorisation in several countries, enter the name of the country (or of one of the countries, if one of them is a Member State, choose this one) that granted the Marketing Authorisation for the actual Investigational Medicinal Product to be used in the trial in accordance with section D.2.1.1.2.
    • Where the product is a Centrally Authorised Product, give the Member State in which the product was intended to be marketed (i.e. the one for which it is labelled) or, if bulk product is used, choose one of the Member States.
  10. In section D.2.1.2.1, answer 'Yes' if the Marketing Authorisation of the IMP to be used in the clinical trial in the Member State concerned by the application was granted by the same Member State. Answer 'No' if the Marketing Authorisation was granted by another country.
  11. Complete section D.2.2 when the IMP has a Marketing Authorisation in the Member State concerned by this application, but the trade name and marketing authorisation holder are not fixed in the protocol.
    12. Tip: You should also have answered 'Yes' to D.2.1 and have completed D.2.1.2 with the name of the Member State to which the application is submitted, and 'Yes' to D.2.1.2.1.
  12. Section 2.2.1 should be answered 'Yes' when the protocol only identifies the INN and the investigator can use whichever brand is locally available.
    The protocol of the clinical trial may specify only the INN of the product used in the trial (for example 'paracetamol') when, for the same active substance there are several different trade names available in the Member state concerned and no one of them is specified by the protocol.
    Note: If 'Yes', give active substance in section D.3.8 or D.3.9 from the IMP details field.
  13. If D.2.2.1 (above) is answered 'Yes' then D.2.2.2 may be 'Yes' or 'No'.
    Select 'Yes' if, in the protocol, treatment regimens for the Investigational Medicinal Product allow different combinations of marketed products (only defined by their INN) used according to local practice at some or all investigator site in the concerned Member State (this case is frequently observed in oncology or HIV clinical trials). In this case each site might have a different combination compared to other sites.
    Note: If 'Yes', give active substance in section D.3.8 or D.3.9 from the IMP details field.
  14. If D.2.2.1 (above) is answered 'Yes' then D.2.2.3 must be 'No'. However, if the answer to this field is 'Yes' then D.2.2.1, D.2.2.2 and D.2.2.4 should be 'No'.
    Note:If 'Yes', give the ATC group of the applicable authorised codes in the ATC code field (level 3 or the level that can be defined) in D.3.3
  15. If D.2.2.1 (above) is answered 'Yes' then D.2.2.4 must be answered 'No'.
  16. In D.2.3.2, if 'Yes is selected, please provide justification for using simplified dossier in the covering letter.
    Tip: Refer to the detail guideline CT1 Section 2.7.3 and Table 1.
  17. In section D.2.4, the term 'authorised' should be understood in the context of Directive 2001/20/ECAcronym: European Commission (that is to say an authorisation, according to Directive 2001/20/EC, has been given for a trial using this Investigational Medicinal Product).
  18. In section D.2.4.1,add the Member States where the use of the IMP has been previously authorised.
    • Multiple selection of Options:To select one value, click the value and then click 'Copy'.
      To select more than one value, hold CTRL then click the other value you wish to select, then click 'Copy'.
      To delete all selected values from the right-hand field, click 'Remove All' button. Note: The above technique can be used for any options organised in the same format of two fields.
  19. Answer D.2.5 according to the Community register on orphan medicinal products (Regulation (EC) no. 141/2000):
    http://ec.europa.eu/health/documents/community-register/html/alforphreg.htm
  20. If the D.2.5 was answered 'Yes', please enter the orphan drug designation number in D.2.5.1.
    Tip: The orphan drug designation number is available on the following website:http://ec.europa.eu/health/documents/community-register/html/alforphreg.htm

    Note: This is in reference to the regulation (EC) No.141/2000 on Orphan Medicinal Products.

  21. Answer D.2.6 as appropriate. If 'Yes', please answer D.2.6.1.1 and D.2.6.1.2 depending on the source of the scientific advice. This scientific advice may be given by a National Competent Authority or by the CHMPAcronym: Committee for Medicinal Products for Human Use. The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the Agency's opinions on all questions concerning medicines for human use. It was established by Regulation (EC) No 726/2004 and replaced the former Committee for Proprietary Medicinal Products (CPMP). (European Medicines Agency) or both.
The sub-section is now complete.

Now click header bar to open the next sub-section (D.3 Description of the IMPThe physical description of the product (e.g white tablet, solution).).

D.3 Description of the IMP

Concerning the completion of the description relating to the previously identified Investigational Medicinal Product(s) to be used in the Clinical Trial.

Once the sub-section is complete click the Next button button at the bottom of the page to move to the next sub-section.

  1. Complete D.3.1 only when there is no trade name. This is the name routinely used by a sponsor to identify the Investigational Medicinal Product in the CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved. documentation (protocol, IB...).
    Note: It is Mandatory to complete D.3.1.and/or D.3.2 if question D.2.1 was answered 'No'.
  2. Complete D.3.2 only when there is no trade name. This is a code designated by the sponsor which represents the name routinely used by the sponsor to identify the product in the CT documentation. For example, a code may be used for combinations of drugs or drugs and devices.
    3. Note: It is Mandatory to complete D.3.1.and/or D.3.2 if question D.2.1 was answered 'No'.
  3. If the product has a Marketing Authorisation in the concerned Member State, include the Anatomical, Therapeutic, Chemical (ATC) code. This is available from the Summary of Product Characteristics (SmPC). Click to add an ATC code field. Click again, to include an additional ATC code.
    Note: It is mandatory to include at least one ATC code in this field if question D.2.2.3 is answered 'Yes'.
  4. In D.3.4, select the pharmaceutical form of the actual Investigational Medicinal Product to be used in the clinical trial from the drop-down menu.
    Note: Mandatory field unless D.2.2 is 'Yes'.
  5. Answer D.3.4.1 'Yes' if the formulation is specifically for paediatric usage.
  6. In D.3.5, Include the duration of administration of the Investigational Medicinal Product to a subject. (e.g. If it is intended, in accordance with the protocol, to treat a subject during 3 weeks, specify 'three weeks'.
    If the Investigational Medicinal Product is not administered on a continued basis, specify the rhythm of the product administration. For example, regarding a clinical trial in oncology, if the treatment is administered at day 1 and day 2 every four weeks, specify 'D1 and D2 every four weeks', mentioning the maximum number of cycles foreseen. This field should NOT be completed by simply indicating 'See protocol'
    Warning: The treatment duration (period of time during which the patient is administered with the Investigational Medicinal Product) is not the same as the period of participation of a patient (period of time during which the subject is followed up within the context of the clinical trial).
    Note: Mandatory field unless D.2.2 is 'Yes'.
    7. Notes on D.3.6:
    D.3.6 sub-sections regarding allowed doses are MANDATORY FIELDS. Choose the most appropriate answers in each sub-section by checking the appropriate box (dose per day or total dose), and by specifying the maximum dose administered (concentration and concentration unit, and the route of administration related to the maximum dose). It is evident that the maximum dose may relate to one of the other strengths or routes of administration for this Investigational Medicinal Product so the same answer may apply to several of the related copies of this Investigational Medicinal Product data in this CTA.. The route of administration should be one of those checked at D.3.7.
  7. In D.3.6.1, specify whether the dose is per day or a total dose, using the radio buttons (also D.3.6.2).
    8. Note: The read only field above the radio buttons displays historical data if an xml created prior to EudraCTEudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC. v8.1.0.1 is loaded.
  8. Then, click Click in the free text field 'D.3.6.1 Specify total dose (number and unit)' and specify the amount of IMP (numeric quantity) administered per dose. Use the drop-down list directly below the text field to specify units.
  9. In 'D.3.6.1 Route of administrationThe path by which the medicine is brought into contact with the body (e.g oral, epidural, intravenous). (relevant to the first dose)', click the drop-down list to specify the route of administration related to the first dose.
  10. In 'D.3.6.2 Specify per day or total', choose the most appropriate answer from 'Dose per day' or 'Total dose' using the radio buttons.
    11. Note: The read only field above the radio buttons displays historical data if an xml created prior to EudraCT v8.1.0.1 is loaded.
  11. In 'D.3.6.2 Specify total dose (number and unit)' click in the free text field and specify the amount of IMP (numeric quantity) administered per dose. Use drop-down list at the next field (D.3.6.2 Route of administration (relevant to the maximum dose)) to specify units.
  12. In D.3.6.2 Route of administration (relevant to the maximum dose), use the drop-down list to specify the units of the dose being described.
  13. In D.3.6.2, click the drop-down list to select the Route of Administration which the maximum dose refers to.
The sub-section is now complete.

Now click header bar to open the next sub-section (D.3.7 Routes of administration for this IMP).

D.3.7 Routes of administration for this IMP

This sub-section simply contains Routes of Administration for the selected Investigational Medicinal Product.

  1. To select one Route of Administration, click the country and then click 'Copy'.
  2. To select more than one Route of Administration hold CTRL then click the Routes of Administration and then click 'Copy'.
  3. Use the scroll bar at the side of the window to move to other options.
  4. Click the Next button button at the bottom of the page to move to the next sub-section.
    5. Note: This is a Mandatory field if your precise term is not available use the free text field and include it in your cover letter.
    Tip:Note that selecting Next button opens section 'D.3.11 Type of IMP' and from there, if applicable, to sections D.4, D.5 and D.6. Only then can sections D.3.8 to D.3.10 for active substances be accessed by selecting 'add active substance' for this IMP at the IMP Identification Index screen.
    You are encouraged to use terms that are not 'non-current'.
The sub-section is now complete.

Now click header bar to open the next sub-section (D.3.11 Type of IMP).

D.3.8 to D.3.10 IMP Identification Details (Active Substances)

This sub-section provides detail on the active substance(s) added to the selected Investigational Medicinal Product.

Note: Users are requested to manually add details in these sections only as a last resort if the other options for registering an active substance are not successful. Please note that substances added in this way will not appear in the substance list in the future. If you plan to use the substance again in future Clinical trial applications, please use on of the other processes on the 'D. MPDMedicinal Product Dictionary (also known as eXtended EudraVigilance Medicinal Product Dictionary). Add Active Substance' page (See ).
  1. In field D.3.8 to D.3.10 IMP Identification Details (Active Substances), specify the International Nonproprietary Name (proposed or final) (up to 150 characters).
    2. Note: .If the product is a combination product, specify the name of all active substances, by adding each active substance separately to the IMP. For marketed products, the INN is available in the SmPC. For EUAcronym: European Union. marketed products, the INN is available in section 2 of the EU SmPC entitled "Qualitative and quantitative composition".
    Another descriptive name may be used in specific situations, for example for products of biological or biotechnological origin that have no INN or proposed INN, or where it is an alternative name which is not registered as INN or proposed INN.
    Note:It is not necessary to answer D.3.8 if D.2.2.3, D.2.2.4 are answered 'Yes'.
  2. If available, specify this active substance's CAS numberChemical Abstract Services (CAS) numbers are unique numerical identifiers for chemical elements, compounds, polymers, biological sequences, mixtures and alloys. A service of the American Chemical Society. (a unique numeric identifier for chemical entities) in field D.3.9.1. CASAcronym: Chemical Abstract Services Number' format is nnnnnn-nnn-c where c is a check digit and leading zeros may be suppressed (up to 12 characters). For more information, please check http://www.cas.org
  3. Click in free text field D.3.9.2 and specify the active substance's (AS) current sponsor code (up to 100 characters).
  4. Click in free text field D.3.9.3 and specify another descriptive name for biological/ biotechnological Products that do not have an INN or Proposed INN (up to 500 characters).
  5. Click in free text field D.3.9.5 and include the full molecular formula for the active substance.
  6. Click in free text field D.3.9.6 and include the accepted chemical/biological description of the Active Substance.
  7. Now, complete details relating to the active substance's strength using fields D.3.10.1 to D.3.10.3.
    8. Note: Please note that in this section the strength / concentration should be given for each different pharmaceutical form and/or strength of the Investigational Medicinal Product being used in the trial (for example amount of active substance per tablet) and not the dose administered to the subject.
    Note on 3.10.1: If a unit for your product is not available in the list, please provide an explanation regarding the unit value in section D.3.9.6.
The sub-section is now complete.

Now click 'Done' to return to the IMP Details screen.

D.3.11 Type of IMP

This sub-section provides detail on the type of the selected Investigational Medicinal Product.

  1. In field D.3.11.1, select 'Yes' if the Investigational Medicinal Product is obtained by chemical synthesis.
    2. Note: In some cases, where there are two or more active substances in one Investigational Medicinal Product, it is possible that both D.3.11.1 and D.3.11.2 would be marked 'Yes'.
  2. Select 'Yes' for Investigational Medicinal Products (IMPs) where the active ingredient(s) are biological product(s) of human or animal origin, or contain biological components of human or animal origin, or the manufacturing of which requires such components.
    3. Note: In some cases, where there are two or more active substances in one IMP, it is possible that both D.3.11.1 and D.3.11.2 would be marked 'Yes'. Also, if D.3.11.2 is marked 'Yes', ensure that D.4 is completed.
  3. If the IMP is considered an Advanced Therapy Investigational Medicinal Product (ATIMPAcronym: Advanced Therapy Investigational Medicinal Product), select 'Yes' for D.3.11.3.
    4. Note: If this field is marked 'Yes', ensure that the following five sub-questions below, as well as section D.5 is completed.
  4. If the proposed clinical trial entails a somatic cell therapy medicinal product, select 'Yes' for D.3.11.3.1.
  5. Select 'Yes' for D.3.11.3.2 if this Advanced Therapy IMP is a gene therapy medicinal product.
  6. Select 'Yes' for D.3.11.3.3 if this Advanced Therapy IMP is a tissue engineered medicinal product.
  7. Select 'Yes' for D.3.11.3.4 if the Advanced Therapy IMP is a combined product involving a medical device?
  8. Select 'Yes' for D.3.11.3.5, if the Committee on Advanced Therapies (CAT) has issued a recommendation for classification for this IMP.
    9. Tip:For more information on the Committee on Advanced Therapies, see CAT Overview
  9. Click in the free text field and specify the Committee on Advanced Therapies (CAT) classification and reference number, if D.3.11.3.5 was 'Yes'. See CAT Overview for more details.
  10. Select 'Yes' for D.3.11.4 if this IMP includes a medical device but does not involve an advance therapy medicinal product.
  11. Select 'Yes' for D.3.11.5 if this IMP is a radiopharmaceutical medicinal product.
  12. Select 'Yes' for D.3.11.6 if this IMP is an immunological medicinal product (such as a vaccine, allergen, immune serum, etc.), whether it is for prophylactic or therapeutic use.
  13. Select 'Yes' for D.3.11.7 if the IMP is a medicinal product derived from human blood or plasma.
    14. Note: If this question is answered 'Yes', D.3.11.2 should also have been answered 'Yes'.
  14. Select 'Yes' for D.3.11.8 if the IMP is of biological or biotechnological origin but does not fit any of the categories listed above and is obtained by extraction from biological material.
    15. Note: If this question is answered 'Yes', D.3.11.2 should also have been answered 'Yes'.
  15. Select 'Yes' for D.3.11.9 if the IMP was produced using recombinant technology.
    16. Note: If this question is answered 'Yes', D.3.11.2 should also have been answered 'Yes'.
  16. Select 'Yes' for D.3.11.10 if this IMP contains Genetically Modified Organisms.
    17. Note: If this question is answered 'Yes', D.3.11.2 should also have been answered 'Yes'. The following two questions should be completed only if the Investigational Medicinal Product is a medicinal product containing genetically modified organisms.
  17. Answer D.3.11.10.1 only if the IMP is a medicinal product containing genetically modified organisms.
  18. Answer D.3.11.10.2 only if the IMP is a medicinal product containing genetically modified organisms.
  19. Select 'Yes' for D.3.11.11 if this IMP contains an active substance of herbal origin.
  20. Select 'Yes' for D.3.11.12 if this IMP is a homeopathic medicinal product.
  21. Select 'Yes' for D.3.11.13 if the proposed clinical trial entails a medicinal product of a type not detailed above. E.g. medicinal gas.
  22. If this is an 'Other' type of IMP, in D.3.11.13.1, specify the type of IMP in the free text field (up to 200 characters).
  23. In D.3.12 free text field, enter the mode of action of the active substance of this medicinal product (up to 500 characters). Abbreviation should be avoided if possible.
  24. Select 'Yes' in D.3.13 if the active substance contained in this IMP is to be administered for the first time in a clinical trial (first-in-human (FIH) clinical trial).
    25. Note: If you answer D.3.13 'Yes', you should also answer 'Yes' in E.7.1.1. and also complete question D.3.6.1.
  25. Click in D.3.13.1 free text field and enter any risk factors identified in accordance with first-in-human guidance (http://www.ema.europa.eu/pdfs/human/swp/2836707en.pdf) (up to 500 characters).
The sub-section is now complete.

Now click other header bars (if applicable) to open futher sub-sections.

IMP Details

The IMP Details table is only visible once you have begun to add an IMP and have, at the very least, progressed through the sub-sections.

Once an IMP is added, it appears in the IMP Details' table:

Tip:Click on the screenshot to view it full size.

In the IMP Details table, you should search for, then add active substances to your IMP entry.

You may also edit, delete or copy an IMP for CTAs involving multiple IMPs.

Below are the details relating to the functionality available in the IMP Details table.

To Add an IMP:
  1. Click 'Add IMP' to start the first Investigational Medicinal Product (IMP) or create another one.
  2. Fill out the details relating to the IMP in all the sub-sections of Section D.
  3. Once an IMP is added, it appears in the IMP Details' table:
    Tip:Click on the screenshot to view it full size.
Options for 'Edit IMP', 'Delete IMP', 'Copy IMP' and 'Add active substance' are displayed for that IMP, which can now be utilised. Additional IMPs may also be added, as necessary.

To continue completing the current IMP, it is recommended to search for an active substance in order to add it to the IMP Details.

To Delete an IMP/Active Substance from IMP:
  1. Click 'Delete IMP' beside the IMP in the table. A warning dialogue appears:
  2. Click 'Yes' to delete the IMP, otherwise click 'No'.
  3. The updated IMP Details screen appears.
  4. The updated IMP Details screen appears.
    Note: Active substances can be deleted from the parent IMP in exactly the same way.
Options for 'Edit IMP', 'Delete IMP', 'Copy IMP' and 'Add active substance' are displayed for that IMP, which can now be utilised. Additional IMPs may also be added, as necessary.

To continue completing the current IMP, it is recommended to search for an active substance in order to add it to the IMP Details.

To Edit an IMP:
  1. Click edit icon 'Edit IMP' beside the IMP in the table that you wish to review and edit.
The entry appears in duplicate directly below the original IMP in the IMP Details table. Click 'Edit IMP' to make any necessary changes to the IMP copy.
To Copy an IMP:
  1. Click 'Copy IMP' beside the IMP in the table that you wish to duplicate.
The entry appears in duplicate directly below the original IMP in the IMP Details table. Click 'Edit IMP' to make any necessary changes to the IMP copy.
To Add an Active Substance(s) to this IMP

    As a first preference, use 'Add Active Substance' on the 'D. IMP Identification' screen to find and add an active substance from the list of available active substances in the eXtended EudraVigilance Medical Product Dictionary (XEVMPDeXtended EudraVigilance Medicinal Product Dictionary.):

    • Click 'Add Active Substance' and the 'D. MPD Add Active Substance' search screen opens (click image to view full size):
      • Active substance search window
    Tip:You may follow all or some of the below steps before performing your search. The more fields completed, the narrower the search.
    1. Click the drop-down to choose the filter to be applied to the 'Active Substance name'. The options are 'contains', 'equals' or 'starts with' (operators).
    2. Now click in the free text field immediately to its right and specify the active substance name, or part thereof, based on your filter criteria.
    3. Alternatively, click in the free text field and specify the 'Substance EudraVigilance Code', which must be an exact match.

      4. Note: The Search for EVEudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA). Number is always an 'equals' search.
    4. When your search criteria are complete, click 'Search'. A successful search returns results (click image to view full size):
    5. Click the button to add the active substance to the IMP Details. There is no limit to the number of active substances that can be added in this way.
    6. If your active substance is not available from the XEVMPDeXtended EudraVigilance Medicinal Product Dictionary., read the text in the onscreen section headed 'If your search did not find the substance you are looking for, consider the following options:'. A number of options are available:
      • A sponsor or their representative registers with EudraVigilance. To learn more about EudraVigilance registration visit EV How To Register pages.
      • Click 'request that the new Substance be added by EMAAcronym: European Medicines Agency' on behalf of the SponsorAn individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a Clinical Trial.. EMA will do this on one occasion per Sponsor organisation, who should in the meantime register with EudraVigilance.
      • If none of the above options are feasible, click 'continue with the Clinical Trial Application' and enter as much information about the substance as you are able. This option should be used only as a last resort since substances added this way will not appear in the substance list in the future. If you plan to use the substance again in future Clinical trial applications, please follow one of the processes above.
    If you successfully found and added an Active substance the IMP Details table appears with the item added.

    Now go to "Section D.8 Placebo Information" for more detailed information.

Once the entire section is completed to your requirements, including all sub-sections, it is suggested you move to the next section ("Section D.8 Placebo Information") or return to the Clinical Trial Application Menu Overview.

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