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Endocrine disruptors Endocrine disruptors. Biocides Biocides. EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use.
Captain Marvel Best Quotes – ‘I’m not what you think I am.’
The Notice to Applicants was first published in and is regularly updated. The European Medicines Agency is responsible for the scientific evaluation of applications for European Union EU marketing authorisations for human and veterinary medicines in the centralised procedure. As the Agency provides relevant information and guidance for companies and individuals involved in developing and marketing medicines for human use in the Union no dedicated chapter on the centralised procedure has been included in the NTA.
To be noted that this guidance is not a NTA document anymore. Regular update of this guidance will be available directly on the relevant website. The shortened period of the "droit de regard" does, however, not apply in the following cases: the draft Commission Decision is not in accordance with the scientific opinion of the EMA; Member States, during the vote, request that the draft Decision is discussed in a plenary meeting of the Standing Committee; or the opinion of the Standing Committee is unfavourable.
The "Notice to applicants", Chapter VI, is going to be updated to this effect. This arrangement applies with immediate effect, i.
An overview of documents replacing the previous sections of Chapter 7 with corresponding website references is available at the following address. To be noted that this guide is not a NTA document anymore and hyperlinks are available on this page for information. Regular update of this common document for centralised and decentralised applications will be available directly on these websites.
Module 1. Guideline on excipients in the label and package leaflet of medicinal products for human use March Annex October - List of the excipients for which specific information should appear in the package leaflet, published on European Medicines Agency website. Latest updates. Agenda - 85th meeting of the Pharmaceutical Committee 17 December Released 26 November Under: Medicinal products. Commission report on the national and European Medicines Agency experience regarding the list of medicines for human use subject to additional monitoring.
Released 18 November Documents and presentations - 84th meeting of the Pharmaceutical Committee 7 November In , five years after his death, Quill was resurrected along with all the other lives claimed by the Snap. He then returned to Earth with the help of Strange, participating in the Battle of Earth where he encountered Gamora from an alternate past.
After the battle, Quill attended Stark's funeral before flying to New Asgard to retrieve Thor, who had decided to go with the Guardians to help them find Gamora from an alternative past. Peter Quill was born in late to Meredith Quill and Ego , making him a hybrid of human and Celestial.
His conception was all part of a plot set up by his father to produce a second Celestial, whose power he could use to complete the Expansion, which involved assimilating millions of worlds into Ego's very being. Peter was only one in thousands of different children that Ego conceived over the course of millions of years, though all who came before him were killed and thrown aside, failing to meet Ego's expectations.
Quill never knew his father, as Ego left Earth shortly after his son was conceived. Quill grew up in St. Charles , Missouri under the care of his mother and grandfather. Throughout his childhood, Quill became something of a wild child, getting into numerous fights. He became very close to his mother, who brought together some of her favorite songs from her childhood into a mixtape she titled " Awesome Mix Vol. When he was eight years old, Quill's mother became afflicted with terminal brain cancer that, unbeknownst to Quill, was caused by Ego, who feared that his son's growing attachment to Meredith would turn him away from his Expansion plan.
His mother's illness worsened over time, and shortly before she died, she gave Quill a present and a note attached to it. In her final moments, she begged Quill to hold her hand, but he could not bear to look at her. She died seconds later, leaving Quill distraught and screaming for her as he was pulled from the room by his grandfather.
Quill is abducted onto Yondu Udonta 's ship. Directly after her death, Quill ran out of the hospital crying, and was suddenly abducted from Earth by the Ravagers. So, he instead decided that they would keep Quill as their own and chose never to tell him about his father. Quill being trained by Yondu Udonta.
The Ravagers taught Quill how to be the perfect thief. Quill later recalled how, growing up in a Ravager clan, Yondu Udonta had often "kicked the crap out of [him]" in order to teach him how to fight and "kept him in terror by threatening to eat [him]". He also told Quill that they kept him because he was "a skinny little kid who could squeeze into places that adults couldn't", therefore making it easier for thieving. Quill is later told that the threat of being eaten was actually a joke, but as a child he believed it to be serious. As he grew older, Quill started going by the name Star-Lord, which was a nickname given to him by his mother.
Quill's extensive Nova Corps criminal record includes 1 count of fraud, 2 counts of public intoxication, 1 count of assault and 1 count of illegal manipulation of a Garmosian Duchess. Though Rhomann Dey picked him up for petty theft on one of Quill's capers, the charge was not put on his record. Star-Lord arrives on Morag to find the Orb. Living in space for 26 years, Quill built up a reputation as the self-proclaimed legendary outlaw "Star-Lord" and continued to work for Yondu Udonta.
During his time with the Ravagers , Quill had become disloyal to them, eventually planning to leave. When Udonta was given a job by the Broker to steal a mysterious item called the Orb from Morag , Quill decided to steal the Orb for himself and flew to the planet. Quill flew his ship to Morag where he used his Holo-Map Projector to locate an ancient temple where he believed the Orb was being held.
As Star-Lord and made his way through all of the various traps and dangers waiting for him in a temple, including little Orloni which had attempted to attack him; he kept himself entertained as he went through the temple by playing his own Walkman and danced to the music, until he managed to locate the Orb inside the Temple Vault , but found it unprotected and so proceeded to use one of his Gravity Mines to pull it out of it's shielded display and steal it, finding the job much easier than he had expected.
Star-Lord is threatened by Korath the Pursuer.
However just as he prepared to get away with his prize, Star-Lord was attacked by Korath the Pursuer and his team of Sakaarans who demanded that he drop the Orb. When Star-Lord tried to claim that he was just a junker, Korath noted that he was clearly a member of the Ravagers. Not believing his stories, Korath then ordered his men to take Star-Lord back to Ronan the Accuser for questioning as Star-Lord's name clearly did not impress Korath at all.
Quill was able to distract Korath and killed his Sakaaran soldiers by using his Plasma Sphere before he then shot Korath with his Quad Blasters. Believing he was now safe, Star-Lord picked the Orb up and made his escape while being chased down by Korath. Star-Lord used his jet boots to pick up speed as he made it to the Milano and used the Gravity Mine again to stop the other soldiers from shooting at him, all while Korath furiously ran closely behind him.
Star-Lord escapes from the Sakaaran soldiers. Having taken off his helmet , Star-Lord started up his ship and flew away from Morag while Korath still shot at him from a large canon, forcing Star-Lord to use his flying skills to dodge the blasts. Once he had gotten away from the Kree soldier, Star-Lord confidently began cheering until he accidentally flew into a blast of steam which almost caused him to crashland until he was just able to regain control of his ship and then continued to make his hasty escape.
Star-Lord is surprised by Bereet 's appearance. While he was flying away from Morag and catching his breath from the ordeal, Star-Lord was then startled when he discovered that his girlfriend Bereet was still inside the ship. Quill had forgotten that she was there when he went on his heist, something which he quickly informed her of while he left Morag in order to take the Orb away and sell it for a huge profit.
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Quill is confronted by a furious Yondu Udonta. While travelling through space and listening to reports on the Kree-Nova War , Bereet then inadvertently answered a call from Yondu Udonta , who informed Quill that he and his Ravagers had arrived on Morag to find that the Orb was already taken.
I'm Only Human After All (Dont Put Your Blame On Me)
Much to Udonta's rage, Quill refused to tell him where he was and what his plans were, as Udonta then threatened him and confronted him about breaking the Ravager code before Quill hung up. Star-Lord brings the Orb to Broker. Star-Lord went to Xandar in order to sell the Orb , saying goodbye to Bereet before he left.
He brought it to the Broker who had made the deal with Yondu Udonta in hopes of selling it to another buyer. The merchant refused to take the Orb after Quill told him that Korath the Pursuer had been working for Ronan the Accuser , who desired to destroy Xandar. Star-Lord attempts to flirt with Gamora. As he was being pushed outside of Broker's Shop , Quill protested Broker's actions before he encountered Gamora , who was standing outside the shop watching the commotion.
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Changing his tone, Quill claimed that the Broker had quit on a deal and did not have any integrity, like he did. Quill then attempted to flirt with Gamora, introducing himself as Star-Lord while Gamora seemed less than impressed by him, despite calling him a man of honor which Quill agreed with. Star-Lord fights against Gamora for the Orb. While Quill continued to try and flirt with Gamora, he was suddenly attacked and kicked in the chest as Gamora took the Orb from his hand and attempted to get away.
Quill quickly used Energy Bolas to trip over Gamora before chasing after her and trying to wrestle the Orb away from her hands. However, Quill quickly found himself being overpowered by the assassin, who drew Godslayer and prepared to kill him while Quill was pinned down and defenseless. Moments before Gamora could execute Star-Lord, however, he was inadvertently saved when Gamora was also attacked by the outlaw duo of Rocket Raccoon and Groot , who both desired the bounty that had been placed on Quill's head by the Ravagers , which stunned him to see well-known species from Earth walking and talking.
While Gamora attempted to fight off the two bounty hunters so she could regain the Orb, Star-Lord attempted to escape, only to have Gamora throw a knife at his hand and cause him to drop the Orb once again. The pair then wrestled for the Orb with Star-Lord losing the fight again and was pinned to the ground and called a fool by Gamora. Refusing to be defeated, however, Star-Lord distracted Gamora by teaser her while he placed one of his Jet Boot Attachments and then activated it, causing Gamora to be sent flying backwards.
While Quill celebrated, he was then captured by Groot, only for Gamora to free him by cutting off Groot's arms. Once the bag was opened, Star-Lord used the chance to shoot Gamora with his Quad Blasters and then attempted to escape on foot with the Orb still in his hand. Star-Lord is arrested by Rhomann Dey. However before he could get away from his attackers, Star-Lord was shot by Rocket's Laser Cannon , causing him to fall to the floor in agony while Rocket laughed at him. After a lengthy chase, all four were eventually apprehended by the Nova Corps , Quill was arrested by Rhomann Dey , who he had previously been arrested by.
Picking him up, Dey teased Quill by mistaking his name as "Star-Prince", much to his annoyance as he was taken away. Once they all arrived in their holding cells, Star-Lord and the others were forced into a line up by the Nova Corps where all of their own criminal histories were presented for Garthan Saal by Rhomann Dey.
Frustrated by this experience, Star-Lord amused himself by giving the middle finger to those looking at him before claiming that it was an accident. Star-Lord is taken to the Kyln for his sentence. The group was sent to the Kyln by Saal to begin their sentence, where they all arrived together and continued their disagreements. Quill compared Rocket Raccoon to a normal raccoon that he remembered from Earth. Quill began questioning what Gamora had planned for the Orb until eventually she revealed to them that she was planning on betraying Ronan the Accuser and selling the Orb to a third party who she refused to name.
Also, Quill wondered why Groot could only say three words repeatedly. Quill then spotted one of the mean guards using his own Walkman, Quill quickly stepped through the doorway into the guard's quarters in order to ensure the Walkman was not lost forever.