Unlike SIC-8, the IFRS:

Like SIC-8, the IFRS requires retrospective application in most areas.

One of these interpretations is SIC-8 First-time application of IASs as the primary basis of accounting.

Thus, like SIC-8, IFRS 1 requires retrospective application in most areas of accounting.

there was some doubt about how SIC-8 interacted with specific transitional provisions in individual Standards.

The IFRS replaces SIC-8 First-time Application of IASs as the Primary Basis of Accounting.

This IFRS supersedes SIC-8 First-time Application of IASs as the Primary Basis of Accounting.

to consolidate all special purpose entities controlled by the transferor (see SIC-12 Consolidation-Special Purpose Entities)."

In the Annex to Regulation (EC) No 1725/2003, SIC-8 First-time application of IASs as the primary basis of accounting is replaced by the text set out in the Annex to this Regulation.

On 29 September 2003 the Commission adopted Regulation (EC) No 1725/2003(2), which endorses interpretations adopted by the Standing Interpretation Committee (SIC).

some aspects of SIC-8's requirement for full retrospective application caused costs that exceeded the likely benefits for users of financial statements.

Interpretations originated by the International Financial Reporting Interpretations Committee (IFRIC) or the former Standing Interpretations Committee (SIC), and adopted by the IASB.

SIC-8 did not state clearly whether a first-time adopter should use hindsight in applying recognition and measurement decisions retrospectively.

If an entity's first IFRS financial statements are for a period beginning before 1 January 2004 and the entity applies this IFRS instead of SIC-8 First-time Application of IASs as the Primary Basis of Accounting, it shall disclose that fact.

In order to facilitate the transition to international accounting standards and international financial reporting standards (IAS/IFRSs), the International Accounting Standards Board (IASB) decided on 19 June 2003 to replace SIC-8 with - IFRS 1:

Moreover, although SIC-8 did not require retrospective application when this would be impracticable, it did not explain whether a first-time adopter should interpret impracticability as a high hurdle or a low hurdle and it did not specify any particular treatment in cases of impracticability.

SIC-8 could require a first-time adopter to apply two different versions of a Standard if a new version were introduced during the periods covered by its first financial statements prepared under IASs and the new version prohibited retrospective application.

historical files of SOPs are maintained,

standard operating procedures (SOPs),

standard operating procedures (SOPs) for inspection,

existence of SOPs for all relevant areas of testing.

procedures exist for revision and updating of SOPs,

any amendments or changes to SOPs have been authorised and dated,

an index to the facility's standard operating procedures (SOPs),

standard operating procedures (SOPs) for analytical support,

SOPs are available for, but not necessarily limited to, the following activities:

the part played, if any, by QA in the review, revision and updating of SOPs.

measurements, observations and examinations were in accordance with the study plan and relevant SOPs,

each test facility area has immediately available relevant, authorised copies of SOPs,

specific SOPs as related to the studies or procedures being inspected or audited,

to determine whether the test facility has written SOPs relating to all the important aspects of its operations, considering that one of the most important management techniques for controlling facility operations is the use of written SOPs.

the biological test system environment is as specified in the study plan or in SOPs for aspects such as temperature, or light/dark cycles,

The objective should be to reconstruct the study by comparing the final report with the study plan, relevant SOPs, raw data and other archived material.

Standard operating procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.

define the powers of inspectors for entry into test facilities and their access to data held by test facilities (including specimens, SOPs (standard operating procedures) other documentation, etc.).

SIC-1:

Unlike SIC-8, the IFRS:

or the former Standing Interpretations Committee (SIC),

IN7. Like SIC-8, the IFRS requires retrospective application in most areas.

One of these interpretations is SIC-8 First-time application of IASs as the primary basis of accounting.

Thus, like SIC-8, IFRS 1 requires retrospective application in most areas of accounting.

(d) there was some doubt about how SIC-8 interacted with specific transitional provisions in individual Standards.

C1 This IFRS supersedes SIC-8 First-time Application of IASs as the Primary Basis of Accounting.

IN1. The IFRS replaces SIC-8 First-time Application of IASs as the Primary Basis of Accounting.

In the Annex to Regulation (EC) No 1725/2003, SIC-8 First-time application of IASs as the primary basis of accounting is replaced by the text set out in the Annex to this Regulation.

(1) On 29 September 2003 the Commission adopted Regulation (EC) No 1725/2003, which endorses interpretations adopted by the Standing Interpretation Committee (SIC).

(a) some aspects of SIC-8's requirement for full retrospective application caused costs that exceeded the likely benefits for users of financial statements.

If an entity's first IFRS financial statements are for a period beginning before 1 January 2004 and the entity applies this IFRS instead of SIC-8 First-time Application of IASs as the Primary Basis of Accounting, it shall disclose that fact.

(c) SIC-8 did not state clearly whether a first-time adopter should use hindsight in applying recognition and measurement decisions retrospectively.

(2) In order to facilitate the transition to international accounting standards and international financial reporting standards (IAS/IFRSs), the International Accounting Standards Board (IASB) decided on 19 June 2003 to replace SIC-8 with - IFRS 1: